Consulting services

Politecnico Di Milano (POLIMI)

Providing expertise in the field of medical robotics (medical imaging for surgical planning, virtual reality, extended reality) to be eventually tailored to specific projects: 1) Definition of applications objectives 2) Data collection, data curation and bias evaluation 3) Preprocessing and optimization of feature extractions 4) Selection of suitable machine learning models, model training and testing 5) External validation 6) Interpretations of models (XAI algorithm applications and development) Keywords: AI, algorithm development, AI testing and validation, Medical Imaging for Surgical Planning, Virtual Reality, Extended Reality

Fondazione Bruno Kessler (FBK)

This service covers all key aspects of development and deployment of AI solutions, based on shallow machine learning or deep learning). State-of-the-art pipelines are generated/improved leveraging on various technonolgies or solutions such as: data encoding, management of missing data, data augmentation and syntetic data generation, model selection and optimisation, hyperparameters tuning, fine-tuning, data shift and transfer learning, reproducibility and explainability. Keywords: Biomedical data Analysis, Deep Learning, CNN, Machine Learning, Image Analysis, Synthetic Data Generation

Multitel (MULTITEL)

Design, Optimization and Small Series Production of Prototypes: The MULTITEL team excels in creating bespoke prototypes and limited series, demonstrating the potential of AI and optoelectronics applications in various domains.

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Evaluation of medical AI using real-world Data and Synthetic Data to create a strong technical AI evaluation report. Method: evaluation of medical AI products, taking into account the differences between subpopulations, sources of bias, metric selection, uncertainty intervals, among others. Keywords: AI performance evaluation, test report

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Specialized training on how to thoroughly evaluate the performance of Medical AI models and create test reports for notified bodies. Medthod: Organisation of in-person and online training for Medical AI companies to enable them to create strong technical AI evaluation reports. Keywords: AI performance evaluation, test report, course

RISE Research Institutes Of Sweden

Method description: Develop and improve AI algorithms utilizing Deep Learning paradigms within Computer Vision, Data Analysis and Natural Language Processing. The service can include suggestions of applications and highlight strengths, weaknesses, or software development. The service is customized according to the SME's needs. Pre-requisites for the service are the analysis of data availability, data-readiness level and customer needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning

Multitel (MULTITEL)

Development and improvement of innovative AI solutions, tailored to the unique challenges and opportunities of the SME. From 1D, 2D, 3D data or multimodal data, MULTITEL develops and improves customized AI models, leveraging its expertise in AI, embedded systems, machine learning, optoelectronics and optics to deliver robust, efficient solutions. With a focus on refinement, MULTITEL also enhances the performance of existing AI models, ensuring they meet the latest standards in speed, accuracy, and functionality.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - MedTech & Digital Health Companies: For developing high-performance AI models on sensitive clinical data without cloud dependency or data sovereignty concerns. - Research Groups: For leveraging state-of-the-art computing infrastructure and ML expertise to accelerate model development. - Startups: For accessing enterprise-grade training infrastructure and clinical AI expertise without heavy upfront investment. **Key Features:** - End-to-end ML/DL pipeline development: data preprocessing, feature engineering, model architecture design, training, and hyperparameter optimization - Support in developing RAG Systems and Agentic AI: on-premise infrastructure for deployment and limited fine-tuning. - Secure on-premises computing clusters at the highest data security standards – no cloud computing required - Access to the High-Performance Computing (HPC) cluster at FAU Erlangen-Nürnberg for large-scale training workloads - Rigorous testing methodology including cross-validation, holdout testing, and subgroup performance analysis - Clinical domain experts from affiliated clinics ensure models are grounded in medical reality and provide valuable feedback for algorithm improvements **Possible Applications:** - Digital Biomarker Development (e.g. Cardiology): Training models to detect arrhythmias, atrial fibrillation, or heart failure decompensation from wearable ECG or PPG signals. - Biomechanical Movement Classification: Building AI models for automated gait pattern recognition, fall risk scoring, or joint load estimation from inertial sensor data collected in motion labs. - Neurological Disorder Detection: Developing classifiers for tremor subtypes, seizure prediction, or cognitive decline indicators based on neurophysiological signals. - Athletic Performance Optimization: Training models that quantify fatigue, predict overtraining, or recommend personalized load adjustments based on biomechanical and physiological sensor fusion. - Injury Risk Prediction & Rehabilitation Monitoring: Building predictive models that identify musculoskeletal injury risk factors or track recovery trajectories from sensor-based movement assessments. - Sports Science Analytics: Developing AI-driven analysis tools for technique evaluation, energy expenditure estimation, or real-time performance feedback during training sessions. - Predictive Patient Monitoring: Training early-warning models for clinical deterioration, therapy non-response, or adverse events from continuous physiological data streams. - Synthetization and Transfer of AI Model to Edge Device: Re-training and quantizing an ML/DL/AI algorithm, so it can be run on an edge device (e.g. wearable), while optimizing performance (inference accuracy, energy consumption per inference, latency etc.) **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Zilinska Univerzita V Ziline (UNIZA)

Tailored development and consultation of AI models, including supervised, unsupervised, and reinforcement learning approaches. This service supports SMEs in designing, training, validating, and deploying AI solutions. Technical details:Python-based frameworks (TensorFlow, PyTorch), model hosting options. Use cases/examples:SME is looking for information on how to evaluate their model or how to design adequate architecture.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Helping to rigorous testing and validation of the developed Multimodal AI models in real hospital environments based on real-world medical images and with collaboration with AI experts and medical staff. In collaboration with the medical staff and advanced deep learning algorithms, test the AI models on datasets not yet seen by the AI to confirm the correct behaviour of the AI. Discussion with medical experts and validation with new data sets (continuous learning) to ensure that the AI is still correct even with new data). Verification that there are no biases. Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Semi-automated performance monitoring of the Medical AI deployed in the clinical practice, following PMS regulation. Making the distinction between deployments where good model performance can be guaranteed and where not. Consultancy services on automated model performance monitoring in the clinical practice, in compliance with Medical Device Regulation (MDR). Keywords: AI performance evaluation, performance monitoring, PMS, PMCF

RISE Research Institutes Of Sweden

Your AI models might be leaking personal data or trade secrets. GDPR and the AI Act expect you to check this — not hope for the best. We deliver reproducible and defensible testing, so your decisions — and your audits — rest on evidence instead of assumptions. Organisations that build or deploy AI models must meet strict privacy and cybersecurity obligations under GDPR, the EU AI Act, and sector‑specific rules. Models can unintentionally memorise and leak personal data through attacks such as membership inference, data reconstruction, and data extraction — creating real compliance and reputational risks. GDPR requires organisations to prevent downstream exposure of personal data and to honour the Right to be Forgotten, which in practice demands testing whether individual training data still leaves detectable traces inside a model. Beyond privacy, AI models may also reveal proprietary or confidential business information, turning leakage into an IP and cybersecurity risk, not just a data‑protection issue. The EU AI Act reinforces this by requiring testing under foreseeable misuse, including privacy‑relevant attacks. LeakPro provides structured, empirical stress‑testing of AI models to measure privacy and IP leakage, validate privacy‑enhancing technologies, and generate audit‑ready evidence for DPIAs, GDPR, and AI Act compliance. This service maps to the following articles within AI-act: • Article 9 Risk management system — Continuous lifecycle risk management to keep your AI compliant and under control. • Article 10 Data and Data Governance — Validate that your training data meets state-of-the-art privacy and security standards. • Article 15 Accuracy, robustness and cybersecurity — Proactively detect and mitigate confidentiality attacks before they become real risks. The audit reports constitute evidence that feeds into the technical documentation (Article 11 — Technical documentation, Annex IV). How can the service help you? • Detect leakage of personal data, sensitive attributes, or proprietary information. • Check data traceability to support GDPR Right‑to‑be‑Forgotten obligations. • Validate and tune synthetic data, federated learning, and differential privacy. • Provide quantitative leakage‑risk indicators for audits, DPIAs, and procurement. • Advise on privacy‑resilient AI design already at investment and planning. How the service will be delivered Logistics • Delivered via RISE secure environments or customer infrastructure. • Supports models across text, tabular, image, time‑series and graph modalities. • Option for iterative collaboration during model development or one‑off audits. Delivery period Engagements are planned in phases depending on the scope, starting with a general assessment (qualitative), followed by attack simulation (quantitative) and reporting. Duration • Short engagement: 3–6 weeks • Complex model audits or PET optimization: 2–4 months Customer requirement • Provide intended use-case, regulatory context, and risk appetite • Documentation of model development and system environment. • Optional: Access to model artefacts and training data for technical study. Deliveries • Tailored attack suite configuration • Execution of privacy and IP leakage attacks • PET tuning recommendations • Compliance‑aligned summary (reporting evidence for GDPR, AI Act, etc) Output • Technical leakage‑risk metrics • Training data traceability assessment (Right‑to‑be‑Forgotten) • Harm‑oriented explanation for DPIAs • Recommendations for mitigation and governance

RISE Research Institutes Of Sweden

Method description: Investigate Data to be usable in an AI context. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

RISE Research Institutes Of Sweden

Method description: Preprocessing Data to be AI-ready. This service can be a preprocessing step to perform other AI services from RISE, for example RISE's service "AI improvement and development". The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning.

Multitel (MULTITEL)

Applicable requirements for AI-based SaMD are identified, including MDR classification (Class I, IIa, IIb, III), IEC 62304, ISO 14971, IEC 62366, and the EU AI Act. A structured gap assessment is then performed across intended purpose, software documentation, risk management, usability, and clinical evaluation. Findings inform a tailored, step-by-step documentation roadmap targeting Class IIa. Recommendations on technical aspects including accuracy, robustness, validation, and end-to-end traceability from requirements to risks to tests, establishing a sound basis for the technical file.

Multitel (MULTITEL)

Technology Watch and Guidance: MULTITEL keeps businesses at the forefront of AI advancements, offering insights and guidance in emerging technologies. Technical Tests and Feasibility Studies: MULTITEL rigorously tests and assess the practicality of AI solutions, ensuring they align with your business needs. Keywords: AI technical support

RISE Research Institutes Of Sweden

Method description: This service performs testing, evaluation and verification of AI systems in light of the EU AI-Act. Methods consists of traditional performance testing coupled with formal methods to prove safety and functionality requirements, if applicable. The requirements put on the models are formulated in collaboration with the customer. RISE performs the corresponding virtual tests and records the results in a test and verification report. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: AI systems, Data Science, Deep Learning, Natural language processing, Machine Learning, Trustworthy AI

Politecnico Di Milano (POLIMI)

Conceiving, developing and optimization of AI algorithmic approaches across the whole pathway: 1) Definition of applications objectives 2) Data collection, data curation and bias evaluation 3) Preprocessing and optimisation of feature extractions 4) Selection of suitable machine learning models, model training and testing 5) External validation 6) Interpretations of models (XAI algorithm applications and development). Keywords: AI, algorithm development, AI testing and validation, Data Curation, Feature Extraction, Learning Models, External Validation, XAI

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

AI-backed services around algorithm improvement are offered after individual consulting. We provide expertise in algorithm improvement for start-ups/SMEs based on their specific needs https://doi.org/10.1109/OJEMB.2024.3356791 Keywords: Algorithm, AI, data science, medical data, agile development

Laboratoire National De Metrologie Et D'Essais (LNE)

Study and assess the maturity of the AI system in regards of the requirements of the AI Act, especially for high risk AI systems (Articles 9 to Articles 15). The service consists of an analysis of the documentation of the AI system provider. In addition to the documentation, a meeting akin to an audit is organized on specific points to better understand the processes used in developping the AI system. A report is provided at the end of the analysis, which contain the observations of the LNE regarding the maturity of the AI system compared to the requirements of the AI Act.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Assisting companies on how to utilize extended reality technologies within their company. Either with their current services and products,with new products or for training and orientation.

Politecnico Di Milano (POLIMI)

This service offers biostatistical consulting relevant to Data Analysis to be obtained through the clinical evaluation procedure and relevant statistical evaluation; Application of MDCG 2020-1 principles in the design of the specific clinical study. Keywords: Clinical investigation, clinical study, clinical evaluation procedure, statistical analysis;

Univerzitna Nemocnica Martin (University Hospital Martin)

Service helps the client company to build a sustainable model that can adapt and grow in a competitive market by focusing on several key components: - Market Research and Analysis: Understanding the market landscape, identifying trends, evaluating competitor business models, defining and segmenting the target customers based on their demographics, behaviours, and needs, identifying their pain points and unmet needs to ensure the business model addresses real customer challenges. - Value Proposition Design: defining the unique value the company offers, focusing on solving customer problems or delivering specific benefits, how the business’s offering stands out from competitors - Revenue Model and Pricing Strategy: exploring sources of revenue, designing a pricing model that reflects the value delivered and aligns with customer willingness to pay. - Key Resources and Activities: determining the essential resources (human, financial, physical, and intellectual) and activities required to execute the business model. - Key Partnerships and Networks: identifying partners who can enhance value, such as suppliers, distributors, or technology providers. - Channel Strategy: determining the optimal channels for promotion and engagement, as well as selling to customers - Costs and Revenue: developing basic cash flow model - Performance Metrics: establishing key performance indicators (KPIs) to measure success Key words: Business consulting, Business development, Business model

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

Consulting support related to all aspects of business model development. Keywords: Business Analysis, business plan, market

Virtual Research Environment / Health Data Cloud

## Overview The Charité Virtual Research Environment (VRE) provides a Secure Processing Environment (SPE) and Trusted Research Environment (TRE) for collaborative processing, exchange, and analysis of human health data in the context of GDPR, AI Act compliance, MDR evidence generation, and Post-Market Clinical Follow-Up (PMCF). The service enables controlled collaborative processing of sensitive health data within isolated and audit-capable project environments aligned with GDPR and institutional information security requirements. The VRE supports isolated project workspaces on shared multi-tenant infrastructure with secure remote access, managed analysis environments, and traceable processing workflows. ### VRE services include: - Secure isolated project workspaces - Secure data exchange between Charité and external partners - Trusted Research Environment / Secure Processing Environment and secure collaboration workflows for sensitive health data like imaging, genetic, or clinical data - Remote Desktop virtual machines - Managed Jupyter and Linux analysis environments - GPU-enabled compute resources - Long-term storage, backup, and recovery mechanisms - Audit logging and traceability support - Monitoring and operational oversight - Guacamole/VPN-based remote access - Support for automated pseudonymisation and anonymisation workflows - SOPs, onboarding, and user support - Project coordination and operational support - GDPR, MDR, and AI Act support processes - Collaborative data analysis and digital evidence generation --- ## How can the VRE help you? The VRE enables secure and GDPR-compliant collaborative research with sensitive human health data that cannot be fully anonymized, including imaging, genomics, clinical, and other highly sensitive biomedical datasets. The platform provides controlled and traceable access to protected data within isolated project environments designed for secure collaborative processing and analysis. The VRE supports interdisciplinary collaboration between research institutions, healthcare providers, and industrial partners while reducing the need for uncontrolled data transfers and decentralized data handling. Managed analysis environments, secure remote access mechanisms, audit logging, and controlled collaboration workflows support reproducible and secure data processing in compliance-sensitive research settings. The VRE can additionally support translational and regulatory-oriented activities such as AI system evaluation, PMCF activities, secure secondary use of health data, federated collaborations, and evidence generation for MDR and AI Act related processes. --- ## How is the VRE accessed? The VRE is primarily accessed through secure remote access mechanisms. Dedicated isolated project spaces are provisioned on Charité-operated infrastructure. Depending on project scope, the service may range from lightweight onboarding and workspace provisioning to fully managed collaborative environments with operational and compliance support. Typical project durations range from several weeks to multiple years. --- ## Provider Description Charité operates advanced research and digital infrastructure environments for secure biomedical and clinical data processing in research and translational medicine contexts. The VRE supports interdisciplinary collaboration between clinical, scientific, and industrial stakeholders in compliance-sensitive environments. --- ## Technical Description The platform is based on shared multi-tenant infrastructure with isolated project environments. Available resources include virtual machines, GPU-enabled compute nodes, storage systems, managed analysis environments, backup systems, authentication and authorization services, and monitoring capabilities. The environment supports secure remote access, auditability, traceability, and controlled data exchange workflows for sensitive health data processing. --- ## Service Customization The service can be customized depending on project requirements, including: - Dedicated or shared compute environments - GPU-enabled processing - Long-term storage requirements - Custom virtual machine sizing - Federated collaboration scenarios - Compliance and documentation support - Enhanced operational support models - Extended onboarding and training - Integration with external infrastructures and workflows

CEED - Charité Healthcare Services GmbH

We develop customized processes, SOPs, and templates tailored precisely to your regulatory requirements.With our clinic-oriented support for generating clinical data, we offer comprehensive assistance with data collection and analysis, as well as access to relevant resources, such as through our university hospital Charité - Universitätsmedizin Berlin. We also assist you in utilizing Real-World Data to collect and evaluate practical data. Furthermore, we conduct literature and database searches to efficiently gather and analyze the necessary information for your clinical studies and clinical evaluations. Keywords: Clinical Data, Data Collection, Data Analysis, Charité - Universitätsmedizin Berlin, Literature Review, Database Research, Data, Real-World Data, RWD, Real-World Evidence, RWE

Univerzitna Nemocnica Martin (University Hospital Martin)

This service provides clinical testing and evaluation of medical device prototypes or healthcare technology solutions in real-world settings. It assesses functionality, safety, usability, and performance under clinical conditions, gathering essential data for further development and regulatory approval. Clinical evaluations are conducted on-site in healthcare environments by trained teams who manage setup, monitoring, and assessment according to standardized protocols, offering detailed reports on clinical performance, usability, and safety. Keywords: prototypes, real-world testing, medical device prototypes, testing

CEED - Charité Healthcare Services GmbH

Our support for conducting the clinical evaluation of medical devices includes comprehensive planning and concept development for your specific clinical evaluation. We develop customized processes, SOPs, and templates tailored precisely to your regulatory requirements. We take care of the creation and continuous updating of the necessary documents, such as the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER), to ensure that your clinical evaluation meets the highest standards. Keywords: Clinical Evaluation, Clinical Evaluation Plan, CEP, Clinical Evaluation Report, CER, Charité - Universitätsmedizin Berlin

Karolinska Institutet (KI)

Comprehensive validation and optimization of Large Language Model implementations in clinical environments through rigorous testing methodologies, prompt engineering, and output verification with healthcare professionals. Our service includes: LLM Output Validation: Consulting advice on systematic evaluation of LLM responses against clinical guidelines, medical literature, and expert validation to detect hallucinations, factual errors, and inappropriate recommendations. Collaboration with medical staff to assess clinical relevance, safety, and appropriateness of generated content. Prompt Engineering Optimization: Development and refinement of clinical prompts using few-shot learning, chain-of-thought reasoning, and structured output formats. Testing prompt variations against real clinical scenarios to maximize accuracy, consistency, and safety. RAG Implementation & Validation: Design and validation of Retrieval-Augmented Generation systems using verified medical knowledge bases, clinical guidelines, and institutional protocols. Ensuring retrieved context is relevant, current, and properly integrated into LLM responses. Clinical Finetuning Strategy: Assessment and guidance on finetuning approaches for clinical use cases, including dataset curation, domain adaptation, and continuous learning strategies. Evaluation of finetuned models against baseline performance and clinical benchmarks. Bias Detection & Mitigation: Identification of demographic, diagnostic, or treatment biases in LLM outputs across diverse patient populations and clinical scenarios. Keywords: Large Language Models; Clinical NLP; Prompt Engineering; Output Validation; Hallucination Detection; RAG Systems; LLM Finetuning; Medical Knowledge Bases; Clinical Guidelines Compliance; Bias Mitigation; Healthcare AI Safety; Human-in-the-Loop Validation; Trustworthy Clinical AI

CEED - Charité Healthcare Services GmbH

Our Clinical Needs Analyses focus on examining specific requirements and needs within the clinic. This can include evaluating processes, workflows, or medical equipment to derive measures and product ideas that improve the efficiency, effectiveness, and quality of patient care, as well as the working conditions of clinical staff. The analyses enable products to be tailored to the specific needs and requirements of the clinic, fostering market-oriented innovations and enhancing efficiency and customer retention. Our Medical Needs Analyses focus on investigating requirements and needs in healthcare, including assessing the current state of research and technology. The analyses provide insights into the prevention, diagnosis, and treatment of diseases, as well as trends and challenges. They serve as a foundation for developing new products and services that meet or exceed current medical standards and support targeted innovation and effective resource utilization. Keywords: Clinical Expertise, Clinical Requirements, Medical Requirements, State of the Art, Market Needs, Literature Research, Interviews, Workshops, Workplace Analyses

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Support SME to define the clinical investigation methodology (number of subjects, study design, endpoints definition, among others) and to write a first synopsis. It may include: Identification & access to medical & other experts advice; Support to get funding research. Keywords: Clinical investigation, clinical study, methodology, synopsis, funding

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Support SME to define the clinical investigation methodology (number of subjects, study design, endpoints definition, among others) and to write a first synopsis. It may include: - Access to expert medical opinion. - Budget proposal for the clinical investigation. - Support to funding research; Keywords: Clinical investigation, clinical study;

Univerzitna Nemocnica Martin (University Hospital Martin)

The Clinical Study Center offers comprehensive support for the design, implementation, and management of clinical trials. This service focuses on ensuring the integrity, quality, and compliance of clinical studies across various medical fields. The center provides expert guidance on protocol development, regulatory submissions, site management, and data collection, ensuring that all trials meet regulatory standards and are conducted ethically. With a dedicated team of experienced professionals, the center facilitates patient recruitment and retention, monitors trial progress, and ensures accurate data reporting.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service includes first meetings with experts in clinical investigation to support the SME in the maturation process of its innovative medical device and define the main steps in the clinical study process depending the SME needs. Access to expert medical opinion. Support to funding research; Keywords: Clinical investigation, clinical study;

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service includes first meetings with experts in clinical investigation to help the SME in the maturation process of its innovative medical device and define the main steps in the clinical study process depending the SME needs. Definition of the SME needs; Confirmation of the product maturity level; Identification & access to medical & other experts advice, inner partners & external providers; Support to estimate funding research. Keywords: Clinical investigation, clinical study, feasibility, expertise, maturity, TRL

Politecnico Di Milano (POLIMI)

Consulting on the design of a clinical protocol for the clinical evaluation procedure to collect clinical data in support to the certification process throughout the lifecycle of the medical device. Application of MDCG 2020-1 principles in the design of the specif clinical study; MDCG 2020-1. Keywords: Clinical investigation, clinical study, clinical evaluation procedure, CE certification process

Istituto Giannina Gaslini (IGG)

Our service can provide consulting for designing Clinical Trials in a realistic pediatric environment; Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination. Prices are subject to change and are only indicative. The final price will be determined in the contract between the service provider and the applicant.

Istituto Giannina Gaslini (IGG)

Consulting for designing Clinical Trials in a realistic pediatric environment. Keywords: Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination;

Univerzitna Nemocnica Martin (University Hospital Martin)

Description of sequence and structure of particular activities of a clinical trial (CT). Selection of a suitable trial design and identification of alternative clinical trial designs and implementation issues. Service includes: Initial Consultation with CT Coordinator: planning of details of a trial such as endpoints and outcomes, sample size calculations, data management, study protocol, randomization, patient and site recruitment, funding, insurance, etc. CT Protocol: elaborating CT protocol for the Investigator (client company! Including necessary documentation kit for CT running (inform consent, donation agreement, etc.) CT Registration: submitting CT protocol to respective authorization body and in Clinical Trials Information System Key words: Clinical trial design, Clinical protocol, Clinical testing, Investigation, Research

Politecnico Di Milano (POLIMI)

Comparative study of competing products in the market of rehabilitation robotics. Support testing protocol design with healthy, elderly and post-stroke subjects and comparison with benchmarking. For Upper Limb robotics see paper DOI 10.1186/s12984-022-01082-8. Keywords: Comparative study, Market Analysis, Healthcare Robotics, Upper Limb

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

Benchmarking analysis reports to help SMEs assess their position in relation to global competitors. Keywords: Competitors; Market; Business

Technische Universitaet Muenchen (TUM)

Consulting activities to enable usage by customers of a virtual testing and experimentation facility for robotic simulation, with a view to achieve one of more of the following outcomes: in silico training and optimization (e.g., reinforcement learning, genetic algorithms, etc.), performance evaluation of AI-based controllers for robotics in virtual testing environment, or definition and implementation of testing & benchmarking scenarios on specific simulators (e.g., Unity, PyBullet, MuJoCo, etc.). Keywords: Robotics; Simulation of modular heterogeneous systems; In silico functional evaluation of algorithms and AI models for robotics; Optimization of algorithms and AI models for robotics

Laboratoire National De Metrologie Et D'Essais (LNE)

Study and assess the development and evaluation process used by the SME/startup in the development of an AI system. The service consists of an assessment of the development process and evaluation of the AI systems. The consulting service method is based on the study of the documentation describing the process and meetings with the AI team. Keywords: Process assessment, process improvement, data qualification, documentation, transparency, tracability, evaluation

Zilinska Univerzita V Ziline (UNIZA)

Development of intelligent, conversational chatbots powered by large language models (LLMs), tailored to specific healthcare, research, or business needs. These chatbots can understand and generate natural language responses, integrate with organizational knowledge bases, and support advanced tasks such as appointment scheduling, information retrieval, or interactive education. Technical details:Python, LLMs, custom datasets. Use cases/examples: SME wants to develop a chatbot service that would help users operate with their AI system.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Providing prebuilt AI pipelines tailored for medical image analysis. Streamlining AI model integration into existing healthcare workflows. Accelerating the deployment of AI solutions in clinical settings. Using MLOps and DVC to accelerate the AI development and deployment with CI-CD pipelines. Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Consolidate a (multicentric) medical database including medical imaging and patient records. Assess the quality control of the medical database regarding data and GDPR requirements; Classification and categorization of the data regarding medical biases Keywords: Data, AI, regulatory, preclinical and clinical testing, surgery

Karolinska Institutet (KI)

Overview The Data Feasibility Service provides an early, structured assessment of whether the health data required for AI validation can realistically be accessed and used within the Swedish healthcare and research data ecosystem. The service focuses on feasibility and risk reduction rather than data delivery. Karolinska Institutet experts assess whether relevant data sources exist, where they are located, and whether the data’s structure, quality, and technical characteristics are suitable for running and validating the proposed AI solution. Legal, ethical, and practical constraints are reviewed at a high level. The outcome is a concise, actionable feasibility assessment supporting informed decisions on whether to proceed with AI validation and potential next‑step data acquisition services. How can the service help you? Before the service, organisations often face uncertainty around data availability, technical suitability, timelines, and regulatory barriers. After the service, they gain a realistic understanding of whether the required data can support their AI model in practice, including whether the data format, volume, and quality are compatible with the intended validation approach. This enables clearer go/no‑go decisions, improved validation planning, and early alignment with clinical relevance and regulatory expectations, reducing the risk of costly delays or infeasible projects. How the service will be delivered? The service is delivered through a structured review led by Karolinska Institutet in dialogue with the requesting organisation. Experts analyse the proposed use case, data needs, and AI requirements against known Swedish data infrastructures and governance frameworks. The work is primarily desk‑based and typically completed within a few weeks, depending on scope. No transfer or processing of health data is required as part of this service. Provider description The Swedish TEF-Health node is a collaboration between Karolinska Institutet, SciLifeLab and RISE, and is led by Karolinska Institutet. Together, we offer world-leading services with our unique collection of core facilities. We can grant services in expert consulting, virtual- and physical testing in the range of in vivo imaging, ex vivo OMICS, pharmaceutical development, simulated healthcare environments, AI-system validation and development, advanced data analysis and other data-driven life science. Technical description Feasibility is assessed by mapping potential data sources and reviewing governance, access pathways, and constraints. The assessment includes data structure, format, completeness, and quality, as well as technical feasibility aspects such as whether the data can support the intended AI model, validation design, and computational requirements. Legal and ethical considerations, including GDPR, Swedish legislation, and the need for ethics approval, are considered at a high level. The service informs but does not replace formal ethics or data access applications. Service customization The service can be tailored to different clinical domains, data types (e.g. imaging, registries, EHRs), and maturity levels of organisations. The depth of analysis depends on the clarity of the use case and data requirements. The service is limited to feasibility assessment and does not guarantee data access or approval by data owners. Use case/ example An SME developing an AI‑based clinical decision support tool requests access to retrospective imaging and outcome data. The service assesses data availability, governance constraints, and whether the data’s structure and volume are technically suitable for running and validating the AI model. The results indicate feasible data sources but significant lead times, guiding the SME to refine its validation strategy before proceeding with full data acquisition.

RISE Research Institutes Of Sweden

Method description: Integration of data from different datasets. Not exclusively, however this service can be performed as a data preprocessing step to "AI improvement and development" service available from RISE. The service is customized according to the SME's needs. Add-on service to other services. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning.

RISE Research Institutes Of Sweden

Method description: Analysis of big datasets. Not exclusively, however this service can be performed as a data preprocessing step to "AI improvement and development" service available from RISE. The service is customized according to the SME's needs. Add-on service to other services. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

Fondazione Bruno Kessler (FBK)

This service covers all aspects regarding the analysis of data useful to understand the task, including problem identification, data curation and preprocessing, statistical and exploratory data analysis, interpretation and visualization. Keywords: Biomedical data Analysis, Data Processing, Data Science.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Consolidate database through curation and data analysing. Keywords: Data, AI, preclinical and clinical testing, surgery

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Combinatorial optimization solution for processes, scheduling and logistics optimization. Provide expertise on how to address large scale routing, scheduling, logistics and other combinatorial optimisation problems using constraint-based local search. Keywords: Resource Planning, Patient Transportation, Process Optimasation

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service offers a comprehensive overview of the medical device market, including insights into product pipelines and category rankings on a global scale. Keywords: Medical Device; Market; Analysis

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Platform:** [DPM-Research](https://www.iis.fraunhofer.de/de/ff/sse/health/mobile-health-lab/managementsystem-klinische-studien.html): A customizable eCRF platform that streamlines data and patient management and documentation in clinical studies, aligned with international standards and data protection regulations. **Who Can Benefit:** - Clinical Researchers: For streamlined data management processes that support robust research methodologies and regulatory compliance. - Regulatory Compliance Specialists: To ensure that clinical studies adhere to required international and local regulations, minimizing risk and enhancing credibility. - Healthcare Organizations: To manage clinical data effectively, improving research outcomes and operational efficiencies. **Key Features:** - Customized Data Management Solution: Provides a tailored data management and documentation platform designed to support clinical research studies. - eCRF Platform: Offers an electronic Case Report Form (eCRF) system customized for collecting and managing clinical research data efficiently. - Compliance with Standards: Ensures all studies are conducted in compliance with ISO 14155 and GDPR (DS-GVO), guaranteeing high standards in clinical investigation and data protection. **Possible Applications:** - Clinical Studies: Supports the management of clinical trial and patient data, ensuring accuracy, integrity, and regulatory compliance throughout the research lifecycle. - Data Documentation: Facilitates comprehensive data collection and documentation, improving the reliability and reproducibility of clinical research findings. **Who we are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Challenge : The client may request from a software solution provider that a copy of the source code be held by a neutral third party. In the case of AI solutions, training data may also be involved. Security and confidentiality are obviously important. Our strength : CETIC routinely offers a secure procedure for retaining the source code of software and can extend this to AI-based software by managing and preserving the datasets used, thus demonstrating the ability to reproduce the protected software. This service enables a procedure to be put in place to preserve the source code of AI-based software by a trusted third party. This service will manage and preserve the datasets used to develop AI models. Keywords: Software Escrow services

Politecnico Di Milano (POLIMI)

Support in the functional evaluation of Human-Robot Interface (motion capture, EMG, EEG, etc) Costs estimation for both prototype development and volume manufacturing to support SMEs/start-up plan and budgeting throughout the product development lifecycle. Keywords: Cost estimation, Prototype development, Volume Manifacturing, Budget Planning, Manufacturing Costs, Product Development Lifecycle, Cost Optimization;

Eucaim

Cancer Image Europe provides a robust, trustworthy platform for researchers, clinicians, and innovators to access diverse cancer images, enabling the benchmarking, testing, and piloting of AI-driven technologies. EUCAIM Platform integrates a dashboard, a catalogue and a federated searching environment to discover Medical Imaging data related to cancer from a distributed federation of data holders. EUCAIM provides in some nodes processing capacity to securely access the data. EUCAIM is mainly intended for Data scientists to develop, validate or improve AI models or image postprocessing tools. The platform is accessible in https://dashboard.eucaim.cancerimage.eu/

HUMANI SC - Hospital network (HUMANI)

Access to clinical and data experts to identify dataset needs.

CEED - Charité Healthcare Services GmbH

Our expert panels and workshops bring together professionals from various clinical areas to provide valuable insights and expertise during early concept, planning, design, and development phases. This collaboration allows for discussions of product ideas, evaluation of technical details and design aspects, identification of potential challenges, and development of innovative solutions that meet the needs of users and patients while adhering to the highest standards. Keywords:Expert Panels, Group Discussions, Clinical Expertise, Requirements Analysis, Workshops, User and Clinical Requirements, Requirements Engineering, Usability Engineering

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Helping companies to evaluate and test extended reality technologies before investing in them. Assisting them in creating new ideas on how to utilize the technologies in their selected field.

Health Data Hub (Plateforme des Données de Santé)

This service provides in-depth data analysis expertise, specifically focusing on the exploitation of the French National Health Data System (SNDS) and, if applicable, its linkage with other datasets. Deliverables include commented R or Python programs for data processing and a detailed report presenting descriptive and analytical results, clear visualizations, conclusions, and recommendations, all to be completed within 60 days.

Health Data Hub (Plateforme des Données de Santé)

This service focuses on technical validation. It provides rigorous evaluation of experimental design, statistical power, reagent specificity, and controls to ensure methodological integrity and data reliability, identifying potential biases or flaws before study commencement.

Health Data Hub (Plateforme des Données de Santé)

This service offers comprehensive scientific protocol authorship, generating detailed, technically sound protocols tailored to your research objectives. It encompasses experimental design, statistical considerations, precise methodological steps, and robust control measures, ensuring clarity and reproducibility for complex studies.

RISE Research Institutes Of Sweden

Federated Learning (FL) is a transformative approach to Artificial Intelligence that allows models to learn from data without that data ever leaving its original location. In the healthcare sector, where patient privacy and data security are paramount, this service enables organizations to collaborate and train powerful AI models across multiple hospitals or clinics while keeping sensitive records safely behind their own firewalls. This service provides a comprehensive framework for designing, prototyping, and implementing distributed AI solutions. Many high-impact healthcare applications are currently stalled because moving data to a central server is either technically impossible due to bandwidth or legally restricted by GDPR and the AI Act. Our service bridges this gap by bringing the "learning" to the data. Technical Note: Federated Learning is used exclusively during the training phase. Once training is complete, the resulting AI model is a standard, standalone tool that can be deployed and used at any location at any time, identically to a traditionally trained model. We work closely with you to investigate the feasibility of federated learning for your specific datasets, ensuring that the resulting AI models are both high-performing and privacy-compliant. As this service is closely linked to our Privacy-Preserving Methods and Implementation offering, we integrate advanced techniques such as differential privacy or secure multi-party computation to ensure that even the model updates themselves do not leak sensitive information. How can the service help you? • Unlock Siloed Data: Train AI on distributed datasets that cannot be moved or merged due to legal (GDPR) or technical constraints. • Enhance Privacy: Minimize data exposure by keeping raw patient records on-premises. • Collaborative Innovation: Enable multiple SMEs or healthcare providers to co-develop a robust "Global Model" that performs better than any "Local Model" trained in isolation. • Regulatory Compliance: Align your AI development with the strict requirements of the AI Act and healthcare data regulations. How the service will be delivered Logistics: The service is delivered through the RISE Applied AI Center and can utilize the V-Platform (a Trusted Research Environment). It can be configured for on-site deployment within your infrastructure or via a cloud-federated setup. Delivery period: Engagements are planned in phases, starting with a feasibility study and moving into prototyping and implementation. Duration: Typically ranges from 3 to 6 months, depending on the complexity of the data architecture and the AI model requirements. Customer requirement: The customer must provide access to relevant use cases, problem statements, and data documentation. While raw data stays with the customer, technical access for the "FL-client" software is required. Deliveries: Prototyping of the FL architecture, integration of privacy-preserving hooks, and technical documentation. Output: A functional federated learning pipeline and a refined AI model optimized for distributed environments. This service is highly modular and can be customized to match your specific industry standards, technical infrastructure, and the specific sensitivity level of your health data.

Zilinska Univerzita V Ziline (UNIZA)

Provision of high-performance computing infrastructure powered by NVIDIA GPUs, enabling SMEs and researchers to train and test AI models in a scalable and secure environment. This service supports deep learning, computer vision, and large dataset processing tasks. Technical details:NVIDIA GPUs, remote access, Docker support, secured environment. Use cases/examples: SMEs without adequate training machines can rent full power of the high-end computers. The computer operates a platform for data storage, model training and evaluation.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

As a non-profit and accredited centre, our experts provide a neutral and independent technical advice and support along the design and implmentation process. Service includes SotA (State of the Art) analysis and positioning, coaching on design choices, studying of alternatives for solutions involving embedded systems, elaborating design reviews, software and hardware architecture reviews, components selection, recommandations, analysis, etc. Keywords: SotA, design review, technical advice, independent expertise

Politecnico Di Milano (POLIMI)

Providing expertise in the field of medical robotics (exoskeletons and surgical robotics), to be eventually tailored to specific projects: 1) Definition of applications objectives 2) Support to the mechanical design of the robotics, mechanical design and embedded sensors 3) Firmware integration and software control 4) Technical, dry and experimental validation Keywords: Robotics Control, Robotics Design, Exoskeleton, Surgical Robot

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - MedTech Companies Seeking Certification: For independent validation evidence required by notified bodies and regulatory authorities. - Clinical Decision-Makers: For objective assessment of AI tool performance before clinical adoption. - Quality & Regulatory Teams: For comprehensive documentation aligned with EU AI Act, MDR Annex XIV, and relevant AI standards. - Investors & Partners: For independent third-party performance verification as part of due diligence. **Key Features:** - Independent, unbiased evaluation of AI model performance on clinical data - Comprehensive quality assessment: accuracy, robustness, fairness, explainability, and failure mode analysis from established assessment framework - Alignment with regulatory frameworks (EU AI Act, MDR, FDA AI/ML guidance) and standards (ISO 24028, CLAIM checklist) - Secure on-premises evaluation – no cloud computing; models and data never leave secure infrastructure - Clinical relevance assessment by domain experts **Possible Applications:** - Fairness & Bias Audits: Independent assessment of whether AI models perform equitably across demographic subgroups (age, sex, ethnicity) in clinical and sports populations. - Pre-Submission Validation (MedTech): Independent performance verification of cardiac AI algorithms (e.g., arrhythmia detection) prior to MDR or FDA regulatory submission. - Post-Market Performance Monitoring: Periodic re-validation of deployed AI models to ensure sustained accuracy as patient populations or data acquisition hardware evolve. - Biomechanical AI Benchmarking: Objective validation of movement analysis algorithms against gold-standard motion capture in laboratory and real-world conditions. - Neurological AI Quality Assessment: Stress-testing seizure detection or tremor classification models across diverse patient populations and recording conditions. - Sports & Rehabilitation Algorithm Verification: Validating AI-based injury risk scores, return-to-play classifiers, or performance metrics against clinical expert assessments and ground truth outcomes. - Comparative Algorithm Studies: Head-to-head benchmarking of competing AI solutions on the same clinically curated dataset to support procurement or partnership decisions. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Univerzitna Nemocnica Martin (University Hospital Martin)

Service suitable for middle and large client organizations striving to build functioning innovation ecosystem. It consists of three interconnected parts: - Assessment of Current State: evaluating current innovation culture, key stakeholders, talents, projects, idea pipelines, processes, partnerships, documentation, infrastructure (including IT), funding & investments and digitalization maturity within client organization. - Developing Roadmap for Future: elaborating simple and understandable path to improve current “status quo” within organization innovation management. Included will be “quick wins” - small, easy-to-implement measures that bring immediate positive results. - Interim Innovation Management: additional optional support to client organization management board. Based on developed roadmap in previous step delivering individual works to establish functional innovation management within client organization for short-term period (up to 6 months). Key words: Innovation, Creative ideas, Spin-off/Startup, Innovation labs, Research & Development & Innovation management

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Along the innovative product/solution development pathway relevant go-no-go decisions should be taken into account. To ensure the suitability of the design and/or the product/solution market receptiveness, critical milestones should be checked in early phases to anticipate the health technology optimal launch. By granting the product/solution a KOL validation, by clinical experts through a systematic assessment approach, in a timely manner, will reduce the risk of failing the next steps of the way. IPN, in collaboration with Coimbra University Hospital – Unidade de Saúde Local de Coimbra (ULS-C) and the synergies settled through the TEF-Health partnership, counts on the expertise of high-tier health clinical professionals to provide new technologies assessment in a 3-step way, 1. Preliminary evaluation: the KOL self-assesses the product/solution provided information, to evaluate its medical purpose assumptions? If it answers an unmet medical need? competitor(s) in the market? Strengths/weaknesses of the technology? etc. 2. Short meeting: a 1:1 one-hour meeting, where the KOL is briefed with a 10-15 mins. demonstration of the product/solution, followed by a discussion of the concerning queries. 3. Expert assessment report: a report is issued addressing insight on the raised hot topics, including suitability strengths, weaknesses, opportunities and threats analysis (SWOT) analysis and useful recommendations/ suggestions to be considered.

Univerzitna Nemocnica Martin (University Hospital Martin)

Service delivers to client company specialized legal services based on the organization or founder(s) needs. It consists of: - Legal Advisory in IP Protection: expert guidance on securing and managing intellectual property rights, including patents, trademarks, copyrights, and trade secrets. It helps businesses prevent unauthorized use and protect their innovations, brand identity, and creative assets from infringement. - IP protection application: submitting the IP protection application on the behalf of the client for particular IP on national or internation (European) level. - Legal advisory on legal form establishment: assists in selecting the appropriate business structure, such as LLC, corporation, or partnership, based on business goals and legal requirements. This guidance ensures compliance with regulations and optimizes tax, liability, and ownership considerations. - Legal form set up: manages the legal steps to formally register a business entity, such as preparing legal documents of incorporation, partnership agreements, or LLC documentation. It includes filing necessary paperwork with government authorities and setting up a compliant legal structure. - Advisory in ​​Obtaining CE Marking: helps businesses understand the requirements for CE marking, which signifies conformity with EU health, safety, and environmental protection standards. It guides companies through compliance documentation, testing, and the assessment process needed to sell products in the European Economic Area. - Obtaining CE Marking: involves the practical steps of testing, certification, and documentation to ensure a product meets EU regulatory standards and qualifies for CE marking. The service also includes coordination with notified bodies or relevant testing agencies to confirm compliance. - Cap Table“ Legal Advisory: provides guidance on managing ownership structure, equity distribution, and shareholder interests within a company. It includes advice on structuring investments, issuing shares, and planning for future financing rounds to ensure equity stability and alignment with business growth plans. Key words: Legal advisory, IP protection, CE mark, Company set up, Legal form, Ownership, Shares

Karolinska Institutet (KI)

## Overview This service provides expert regulatory support for startups, SMEs, and research projects working on AI-based and digital medical technologies. Provided by SMAILE at Karolinska Institutet, the service helps navigate the complex requirements of the EU Medical Device Regulation (MDR), especially for software as a medical device (SaMD), wearable devices, and AI-powered diagnostics. Guidance includes risk classification, conformity assessments, documentation gap analysis, and strategy development. We provide expertise and support in: • EU MDR readiness and gap analysis • Regulatory strategy for AI-based and digital devices • Documentation review for CE-marking ### How can the service help you? Whether you’re preparing for a clinical trial or a CE submission, this service helps reduce regulatory risk and accelerates your go-to-market process. It is particularly valuable for early-stage developers unfamiliar with MDR Annexes, UDI, and performance evaluations. ### How will the service be delivered? Delivered virtually, with review sessions and feedback meetings. For complex projects, hybrid support is available, including hands-on workshops at the Karolinska Institute. Timeline varies: from a 1-week consultation to a 6-week full regulatory mapping. ## Additional Information ### Provider Description SMAILE supports startups and innovators through regulatory guidance for digital health and AI technologies. The team includes experts in MDR, AI Act, clinical evaluation reports (CER), and technical documentation for medical devices. ### Technical Description The service includes mapping your product against MDR Annex VIII, evaluating classification and intended use, and reviewing QMS and risk management documentation. ### Service Customization Custom modules include technical documentation audits, clinical evaluation design support, and guidance for combination products or health apps.

CEED - Charité Healthcare Services GmbH

Our medical device advisor training is aimed at all employees of medical device manufacturers and trading companies who inform about medical devices and provide training on their use. The training delivers practical, product- and company-independent fundamental knowledge required for this role. It clearly outlines the rights, responsibilities, and obligations of medical device advisors and is supported by the legal requirements of the MPDG and MDR. It is suitable for both new professionals entering the field and for updating and refreshing existing knowledge. Keywords: Training Concept according to MPDG, Rights and Responsibilities of Medical Device Manufacturer Employees, Fundamental Knowledge, Clinical Insights, On-Site or Online

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service provides access to a network of organizations within the Portuguese health ecosystem and offers support in identifying and connecting with specific partners critical to the development of innovative solutions. Keywords: networking, partnerships

CEED - Charité Healthcare Services GmbH

Our clinic-oriented Post-Market Clinical Follow-Up (PMCF) support offers you comprehensive assistance with the planning and development of your PMCF activities. We develop customized processes, SOPs, and templates for updating the clinical evaluation, precisely tailored to your regulatory requirements. Our service includes the creation of all necessary documents, including the PMCF Plan and Report. Additionally, we support you in conducting PMCF studies, registries, and surveys, particularly at the university hospital Charité. With our expertise, we ensure that your PMCF activities not only comply with regulatory requirements but also provide valuable data for the continuous monitoring and improvement of your medical devices. Keywords:Post-Market Clinical Follow-Up, PMCF, Clinical Evaluation Update, PMCF Plan, PMCF Report, PMCF Studies, Register, Surveys, Charité - Universitätsmedizin Berlin

Politecnico Di Milano (POLIMI)

To facilitate post-market surveillance implementation, as introduced by the MDR, this service offers pro-active information retrieval relevant to reported problems in medical devices by scanning and aggregating query results from official public databases of competent national authorities. Keywords: Post market surveillance, Risk analysis, Pro-active market vigilance, MDR, Field safety notice, PSUR

CEED - Charité Healthcare Services GmbH

Our Post-Market Surveillance (PMS) support offers comprehensive assistance with post-market monitoring, such as planning and developing your PMS activities. We develop customized processes, SOPs, and templates precisely tailored to your regulatory requirements. Additionally, we handle the creation and regular updating of important documents such as the PMS plan, PMS report, and Periodic Safety Update Report (PSUR). Keywords: Post-Market Surveillance, PMS, Post-Market, PMS activities, PMS plan, PMS report, Periodic Safety Update Report, PSUR, safety report, trend analysis, continuous surveillance, Charité - Universitätsmedizin Berlin

Politecnico Di Milano (POLIMI)

In order to contribute to pre-market evaluation for a certain new technology, risk assessment based on the search for reported problems for products of similar category already on the market will be provided by scanning and aggregating query results from official public databases of competent national authorities. In addition, relevant manufacturers information to determine the actual market share will be also provided. Keywords: Risk analysis, Pre-market evaluation, New technology

RISE Research Institutes Of Sweden

Method description: Privacy-preserving and Federated analysis of the solution adapted to the customer Data and use cases. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning.

Univerzitna Nemocnica Martin (University Hospital Martin)

Testing assumptions about a product and its target market to ensure there’s demand and that the product meets customer needs. Within the service client can choose from individual testing option or their combination: - Customer Interviews and Surveys: talking to potential customers to gain qualitative insights into their needs, pain points, and buying criteria and/or sending surveys to gather data on a broader scale. - Testing Minimum Viable Product (MVP) with Early Adopters: offering the MVP to group of customers who like to try new products and collect feedback on product usability, satisfaction, and willingness to pay. - Analysing Market Demand through Landing Pages or Pre-Sales: setting up a simple landing page describing the product and its benefits with a call-to-action, such as signing up or pre-ordering. Using online advertising to drive traffic to the landing page and measuring the conversion rate of sign-ups or pre-orders. - A/B Testing: running A/B tests - experiment with different versions of client MVP, landing page, or pricing to see which elements resonate best with the target audience. Key words: Business consulting, Product testing, Market analysis, Market validation, Customer feedback

Politecnico Di Milano (POLIMI)

We offer a methodological approach to support SMEs/start-ups in the early development stages of a surgical robotic solution. We provide expertise in methodological approaches in the field of medical robotics. https://journals.sagepub.com/doi/full/10.1177/1729881419865805 Keywords: Requirement Elicitation Studies, Medical Robotics

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Development of PoCs (Proof of Concepts) or demonstrators involving data collection from distributed and heterogeneous data sources (IoT sensors, devices, APIs, etc.) based on lightweight but yet flexible and evolvable middleware architecture leveraging data modeling and data semantics. This service is customised to the customer need and PoCs can cover one, part or all of the following : IoT (wireless) protocols interfacing, gateway integration and programming, implementation of data processing, transformation and transmission to remote platforms. PoCs leverage DMWay toolbox where relevant ( https://asset.cetic.be/en/dmway/) Keywords: IoT, medical devices, wireless communication,firmware, middleware, PoC , prototype, gateway

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Assessment of the architectural quality of AI software. The service offers a high-level assessment of the quality factors in AI-based software architecture, from design to implementation, using CETIC's "Archicheck" methodology. The assessment is based on ISO25000 and provides scores for each criterion, as well as an overall score for architectural design quality. The assessment offers a quick, high-level overview of the quality of an application's architecture and pragmatic recommendations for rapidly improving problem areas. Keywords: quality development

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Biological evaluation is a critical process in the development of medical devices, aimed at assessing their safety and biocompatibility when interacting with biological systems. This evaluation ensures that the materials used do not cause adverse biological responses, and is guided by the ISO 10993 family of standards. To systematically address these requirements, it is essential to develop a Biological Evaluation Plan (BEP), detailing the specific tests and assessments needed based on the device’s intended use, material composition, and duration of contact with the body. The findings from this process are compiled into a Biological Evaluation Report (BER), which summarizes the results, demonstrates compliance with ISO 10993, and ensures the device’s safety and regulatory approval.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Compliance with MDR requires a robust Clinical Evaluation to demonstrate the safety, performance, and clinical benefits of a medical device. This process involves a systematic assessment of clinical data related to the device. In the context of Clinical Evaluation, IPN services include: - Development of a Clinical Evaluation Plan (CEP): Defining the scope, methodology, and objectives of the evaluation, tailored to the device and its intended use. - Identification and Appraisal of Clinical Data: Systematic collection, appraisal, and analysis of clinical data from existing literature, clinical investigations, and post-market sources. - Elaboration of the Clinical Evaluation Report (CER): Compilation of all findings into a detailed CER aligned with MDR requirements to support regulatory submissions. - Gap Analysis: Evaluation of existing clinical data to identify gaps and strategies to address deficiencies, ensuring compliance with regulatory standards. This service ensures a systematic and compliant approach to clinical evaluation, supporting regulatory approval and lifecycle management of medical devices.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The placing of a medical device or an IVDon the market is preceded by an evaluation of the residual risks related to quality, safety and performance. However, this evaluation shall continue throughout the entire lifecycle of the device, including the post-market period. Post-market surveillance allows manufacturers to collect and analyze experiences of the actual use of medical devices. Based on the outcome of this analysis, further actions such as incident reporting to competent authorities, field safety corrective actions or safety warnings to users may be required. Post-market surveillance activities are planned in the Post-market Surveillance Plan and the data is compiled in the Post-marketing Surveillance Report - PMSR (for class I medical devices) or the Periodic Safety Update Report (for class IIa, IIb and III medical devices or class C or D IVDs). Our unit assists in the elaboration of the PMS Plan with the definition of actions and also the elaboration of PMSR or PSUR

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN provides expert guidance in identifying the applicable pre-clinical tests required for medical devices, ensuring alignment with regulatory standards and facilitating a seamless pathway to market. The focus is on determining the specific tests based on the unique characteristics of the device, such as whether it is sterile, active, implantable, or software-based. Examples of pre-clinical tests include electrical safety and electromagnetic compatibility (EMC) evaluations, biocompatibility assessments (e.g., cytotoxicity, sensitization, and irritation testing), cybersecurity analysis, sterilization and cleaning validation, microbiological tests (e.g., bioburden and sterility), and stability or shelf-life studies. Additionally, IPN’s team assist in identifying accredited laboratories with proven expertise to conduct these tests, guaranteeing reliable and regulatory-compliant results.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The IPN team conducts thorough audits of Quality Management Systems (QMS) to ensure compliance with key regulatory requirements, including ISO 13485, FDA’s 21 CFR Part 820, and the European MDR and IVDR regulations. Independent auditors perform on-site or remote assessments to evaluate the effectiveness and conformity of the QMS, supporting both initial certification audits and ongoing surveillance or recertification audits.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Compliance with IVDR requires a Performance Evaluation, including the assessment and analysis of data to establish or verify the scientific validity, the analytical performance, and, where applicable, the clinical performance of an IVD. IPN’s support in this area includes: • Development of the Performance Evaluation Plan (PEP) • support in demonstrating the scientific validity and the analytical and clinical performance • Elaboration of the Performance Evaluation Report (PER) • Gap Analysis on scientific validity, analytical and clinical performance data This service provides a structured and regulation-compliant approach to performance evaluation, facilitating both regulatory approval and the ongoing lifecycle management of IVD devices.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

According to Article 15 of the MDR, the manufacturer of medical devices is required to have, within its organization (or an external person for small companies), a person who is responsible for regulatory compliance and with the explicit responsibility to ensure that all 'Manufacturer's Obligations' are met (Article 10). Our team includes competent and experienced people to play the role of Person Responsible for Regulatory Compliance, ensuring: - The verification of the conformity of medical devices according to the QMS (Article 10(9), MDR); - Maintenance and updating of technical documentation (Article 10(4) and (6), MDR); - Compliance with market surveillance obligations (Article 10(10), MDR); - Fulfilling incident reporting obligations (Article 10(13), MDR).

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN performs gap analysis, in order to assist the success of MD or IVD development projects, with the ultimate goal of making the devices available in the intended markets. This analysis identifies data gaps in projects, procedures, and product regulatory roadmaps, considering the regulatory requirements. The regulatory/market assessment gap analysis consists, among others, of the following steps: map out current policies and procedures; outline the regulatory and normative framework and determine which requirements the organization and/or project needs to meet; identify and analyze the gaps; establish concrete recommendations on how to resolve the gaps.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Risk evaluation gap analyses are designed to assess the potential risks and vulnerabilities associated with medical devices or IVDs. The IPN team assists companies by conducting comprehensive gap analyses of current risk identification and evaluation processes for their devices, identifying any shortcomings in the existing risk management framework. Leveraging the principles outlined in ISO 14971, the team evaluates the adequacy of risk management practices and ensures compliance with international standards. Based on this initial evaluation, the team can also support the development of an action plan to mitigate or eliminate identified risks effectively.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN includes qualified trainers who provide specialized training in the area of medical device regulation, with our greatest experience being in Regulation (EU) 2017/745, Regulation (EU) 2017/746, Risk Management (according to ISO 14971), Quality Management Systems (according to ISO 13485) and Performance and Clinical Evaluation. All trainings are accredited and can be in a face to face or online mode, divided into asynchronous sessions and synchronous sessions. In addition to specialized training and mentoring services, we also offer free webinars on the topics mentioned above.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The MDR and IVDR states in Article 10 (9), the requirements for the Manufacturer’s QMS. Despite not being specified, ISO 13485 is the most suitable quality management systems standard for medical devices companies. In the US, manufacturers must comply with the FDA’s Quality System Regulation (21 CFR Part 820), which outlines similar requirements for design, production, and process controls. The IPN helps medical device and IVD companies implement their QMS in compliance with the applicable regulatory framework. So, in order to meet the requirements and also operators’ specific needs, IPN team work closely with each section or department representatives.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The European database on medical devices (EUDAMED) improves transparency and coordination of information regarding medical devices available in the European market. The database consists of 6 modules, and IPN can assist organizations in using the modules already available, that is, in the registration of manufacturers, importers, and authorized representatives in the "Actor Registration Module" with the issue of the “Single Registration Number” (SRN), and in the device registration in the “UDI/Device Registration Module”

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN team is able to bridge the gap between companies and the Notified Bodies. More specifically, the team supports the management of communication with the Notified Bodies during the certification submission process. This support includes guidance and support for the Notified Body selection according to the applicable product codes, assistance in requesting quotes, filling in the form, Gap analysis of the TD prior to submission and support in responses to Notified Bodies’ requests for additional information about submissions.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

With special focus on active devices, IPN supports manufacturers, distributors, and importers of MDs and IVDs, in the CE marking process taking into account the applicable requirements of Regulation (EU) 2017/745 (Medical Device Regulation - MDR) or Regulation (EU) 2017/746 (In Vitro diagnostic Medical Device Regulation – IVDR), as applicable. In this context, IPN supports the implementation and review of the Quality Management System (QMS), together with the elaboration or revision of the Technical Documentation (TD) of the device (under Annex II and Annex III of MDR or IVDR). IPN also support the company, depending on the device class, with the submission of the certification request to a notified body.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN provides services related to the Unique Device Identification (UDI) system, which ensures proper traceability of the devices throughout the distribution chain and by the user. IPN assists in the registration of organizations within an accredited UDI issuing agency, in the creation and correct use of UDI codes (UDI-DI, UDI-PI and basic UDI), ensuring that UDI data is formatted correctly for submission to EUDAMED and/or Global Unique Device Identification Database (GUDID – FDA). IPN also provides support in the maintenance of data related to the UDI.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Vigilance means to be watchful of the possible danger or difficulties. The medical device Vigilance System is designed to collect information on post-market incidents or adverse events related to medical devices and, where appropriate, distribute or disseminate such information to prevent adverse events from recurring. This indicates that medical device manufacturers must have a dedicated system in place for the management of vigilance activities. It is the manufacturers or, if applicable, the European Authorized Representatives’ obligation to notify the Competent Authority in case of any incident with their devices. In the regulatory unit, we help manufacturers to implement medical device Vigilance Systems in compliance with all legal and regulatory requirements and also support incident reporting as well as incident investigation and further actions implementation.

CEED - Charité Healthcare Services GmbH

Our company-specific modular MDR-workshops offer hands-on training on various relevant topics of the Medical Device Regulation (MDR) and the general medical device field. These intensive workshops are divided into compact and practice-oriented modules that cover the key requirements of each respective topic. An example is the Module 1 workshop “Regulatory Requirements for Your Medical Device,” which provides a compact and practice-oriented overview of the key regulatory requirements in the medical device field. The workshop content is tailored to the company’s specific needs beforehand, and additional topics can be booked in modular fashion. Thus, specific topics such as Clinical Evaluations, Technical Documentation, and Quality Management can be booked individually and customized to the company's needs. The content is structured in such a way that participants are optimally prepared for the MDR requirements and can directly apply their knowledge. A regular workshop usually lasts two days and includes gap analyses in the form of checklists as well as the creation of an action plan. Practical exercises additionally introduce the creation of documentation and processes tailored to the individual company. Participants also receive current informational materials and clinical insights from practice. Our workshops provide companies with the opportunity to not only further educate individual employees but also empower their team to implement the MDR and other regulations within the company. Our goal is to strengthen and support the team in jointly managing the various regulatory requirements and to guide the transition from overview and understanding to practical implementation. Keywords: MDR Workshop, MDR, Medical Device Regulation, Modular Workshops, Hands-On Training, Medical Devices, Regulatory Requirements, Practical, Gap Analyses, Action Plan, Clinical Evaluation, Quality Management, Usability, Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Charité - Universitätsmedizin Berlin

CEED - Charité Healthcare Services GmbH

Our clinic-oriented regulatory strategy consulting offers comprehensive, individualized advice and support on specific issues in the medical device field. We assist you with product identification, clarify demarcation questions, and support product classifications as well as the selection and implementation of the conformity assessment procedure. Additionally, we maintain close contact and communication with the Notified Body to effectively meet your requirements. Our service also includes consulting on Quality Management Systems according to ISO 13485 and re-certification. Our experts support you in technical documentation, conduct gap and requirements analyses, and prepare you for inspections. We also offer internal audits to ensure that your systems and processes comply with current regulatory requirements and are continuously improved. Our consulting topics particularly include clinical evaluation, including advice on clinical strategy and clinical benefits, as well as equivalence assessment. We provide comprehensive advice on the selection of clinical data, determine the type and extent of required data, and recommend suitable data sources and methods of data collection, including Real-World Data (RWD). Furthermore, we support the assessment of evidence levels and classes, as well as ensuring data quality and quantity. In the area of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF), we offer consulting on the development of PMS and PMCF strategies and support in individual PMS and PMCF activities such as studies and surveys. Additionally, we provide advice on the establishment and implementation of usability engineering and requirement processes to optimize the usability of your medical devices. Keywords: Regulatory Strategy, Consulting, Medical Devices, Intended use, Product Classification, Conformity Assessment Procedure, ISO 13485, Technical Documentation, Gap Analysis, Inspections, Internal Audits, Clinical Evaluation, Clinical Data, Real-World Data (RWD), Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Usability Engineering, Charité - Universitätsmedizin Berlin

CEED - Charité Healthcare Services GmbH

Our requirements analyses during design and development phases focus on the development of product ideas and include detailed investigations to identify technical, functional, and usability requirements. The analyses aim to define the exact specifications of the product, identify potential design improvements, and ensure that all development goals are met. They help in developing high-quality and marketable solutions that comply with industry standards and requirements. Requirements analyses may involve various activities, such as user interviews, workshops, and workplace and workflow analyses. Keywords: Requirements Engineering, Functional Requirements, Usability Requirements, Specifications, Usability Engineering, User Interviews, Expert Panels, Workplace & Workflow Analyses

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers: For strengthening study designs and hypotheses with a comprehensive understanding of existing literature. - Medical Product Developers: To advance the development of innovative medical solutions by integrating scientific research insights. - Academics and Healthcare Professionals: For engaging in scholarly dissemination of research, raising the profile and recognition of their work. **Key Features:** - Systematic Literature Research: Conducts comprehensive, literature searches to establish the scientific foundation for clinical investigation plans, regulatory submissions, and product positioning. - Clinical Investigation Plan (CIP) Development: Authors complete, ISO 14155-compliant study plans including objectives, design, endpoints, visit schedules, and statistical considerations. - Data Management Planning: Develops detailed DMPs covering database design, data collection procedures, validation rules, coding dictionaries, and quality assurance workflows. - Biostatistical Analysis: Provides full statistical support from sample size calculation and analysis plan development through to confirmatory analysis, subgroup evaluations, and results interpretation. - Clinical Investigation Report (CIR): Produces comprehensive final study reports documenting methods, results, and conclusions in accordance with ISO 14155 and regulatory expectations. - Scientific Dissemination & Publication: Supports or leads the preparation of peer-reviewed manuscripts, conference abstracts, and strategic dissemination planning. - Product Development Guidance: Translates scientific evidence into actionable recommendations for medical product design, differentiation, and clinical positioning. **Possible Applications:** - MDR Clinical Evaluation Support: Conducting systematic literature reviews and writing clinical evaluation reports (CER) to fulfill MDR Annex XIV requirements for medical device certification. - Planning Investigator-Initiated Trials: Developing robust CIPs and DMPs for academic research groups conducting clinical studies on novel sensor technologies or digital health solutions. - Regulatory Submission Documentation: Producing the complete documentation package (CIP, SAP, DMP, CIR) required for notified body review or competent authority submissions. - Biostatistical Consulting for MedTech Startups: Providing sample size calculations, endpoint selection guidance, and analysis strategies for companies designing their first clinical study. - Multi-Center Study Coordination: Harmonizing documentation, data management, and statistical reporting across multiple investigational sites. - Scientific Visibility for Industry Partners: Transforming proprietary study results into high-impact publications, raising the scientific profile of commercial innovations. - Grant Proposal Support: Strengthening research funding applications with solid literature foundations, well-designed study concepts, and credible statistical frameworks. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

CEED - Charité Healthcare Services GmbH

CEED supports startups, SMEs and healthcare technology companies in the structured preparation of clinical, operational and regulatory projects within the Charité ecosystem. The service focuses on creating a structured foundation for subsequent clinical project implementation, including: * project scoping, * documentation review, * stakeholder alignment, * clinical and regulatory assessment, * and project and cost planning. The service addresses common early-stage challenges such as: * unclear clinical project scope, * regulatory and evidence uncertainty, * identification of suitable Charité stakeholders, * and limited transparency regarding feasibility, timelines and costs. Activities include: * review of product, project and scientific documentation, * identification and initial engagement of relevant Charité stakeholders, * initial assessment of clinical, operational and regulatory project requirements, * development of project roadmaps, * and preliminary cost and implementation planning. Depending on project maturity and requirements, the service may include integration with: * clinical departments, * institute of medical informatics, * data and research infrastructure, * regulatory and ethics interfaces, * and operational study support structures. The service is designed to establish a structured basis for future clinical validation, PMCF, real-world data or implementation projects within complex hospital environments.

Zilinska Univerzita V Ziline (UNIZA)

Consulting and development of serious games using Unity for healthcare, training, and educational applications. These interactive tools are designed to engage users while collecting valuable insights, supporting behavior change, or improving clinical and learning outcomes across multiple platforms including VR and AR. Technical details:Developed in Unity; supports WebGL, Android, Windows, VR/AR platforms. Use cases/examples: An SME with an AI system wants to develop an interactive and immersive training application. This application can be deployed as a virtual reality, server-client or standalone PC application.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers and Study Designers: For leveraging AI capabilities to refine and finalize study protocols, enhancing their effectiveness and feasibility. - Medical Product Developers: To assess the clinical viability of new products and solutions, ensuring they meet necessary evaluation criteria before market introduction. - Research and Development Teams: For innovative project development utilizing cutting-edge AI technologies to optimize research outcomes. **Key Features:** - AI-Driven Protocol Parsing: Leverages artificial intelligence to automatically parse, structure, and analyze clinical study protocols, extracting key parameters and identifying inconsistencies or gaps. - Feasibility Assessment: Conducts detailed evaluations to determine the viability of clinical studies for medical products, ensuring alignment with research goals and regulatory standards. - Design Optimization Recommendations: Generates actionable suggestions for protocol refinement – from endpoint selection and visit schedules to sample size considerations and risk mitigation. - Regulatory Alignment Check: Automatically flags protocol elements that may conflict with applicable standards (ISO 14155, MDR, ICH-GCP) or require additional justification. - Expert-in-the-Loop Guidance: Combines AI-generated insights with human expert review from clinical and technical specialists to deliver validated, trustworthy recommendations. **Applications:** - Study Protocol Evaluation: Employs AI technologies to enhance the accuracy and efficiency of protocol assessments, identifying potential challenges or areas for improvement. - Clinical Feasibility Analysis: Provides critical insights into the practicality of proposed research projects, aiding in the decision-making process for medical product development. - AI-Enhanced Clinical Research: Supports the integration of AI tools to streamline clinical study planning and execution. **Who we are:** The **Fraunhofer IIS** has established the **"Center for Sensor Technology and Digital Medicine"** in cooperation with the University Hospital Erlangen and the University of Erlangen-Nuremberg to enhance healthcare efficiency through **sensors** and **digital solutions**. This center focuses on integrating **innovative medical technologies** like **patient-specific therapies**, **digital health applications**, **medical diagnostics** via **wearables**, and **robotic systems** for care. Located at the University Hospital Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Univerzitna Nemocnica Martin (University Hospital Martin)

The initial consulting session with duration of 2 hours for a small-to-medium enterprise (SME) focuses on understanding the client's needs, identifying key challenges, and setting a foundation for a successful cooperation. Here’s a structured breakdown of the session: - Introductions: brief background of the consultant and firm. - Objective Setting: explaining the purpose of the meeting and set clear expectations for the session. - Understanding client’s background: gathering information about the SME’s history, mission, vision, and values to understand its foundational context. - Discovery and needs assessment: reviewing the SME’s core business, products/services, and key markets, current challenges and SME's top pain points (e.g. financial performance and cash flow issues, operational inefficiencies, marketing and sales challenges, talent management and retention, regulatory or compliance needs) - Setting up next steps: plan for utilization of TEF services a.k.a. “plan for success” - Open Q & A: answering any client questions or share additional thoughts, gathering feedback Key words: business consulting, business development, needs assessment, “plan for success”

Istituto Giannina Gaslini (IGG)

Our service can provide consulting on designing, modelling, validation and testing of Trustworthy AI models in a realistic pediatric environment, it can provide information on the most relevant applications, Data types, needs, pitfalls, and peculiarities of a typical pediatric environment. It can provide support for typical challenges and solutions on data governance and infrastructures with acknowledged scientists in AI for pediatric needs. Service can connect company with experts in various pediatric medical disciplines; Hospital organisation; AI applications in pediatrics; Data exchange standards and infrastructures; Optimal algorithm development and testing for pediatrics; Methods for AI testing and validation; Data science; Data types in paediatrics. Prices are subject to change and are only indicative. The final price will be determined in the contract between the service provider and the applicant.

Health Data Hub (Plateforme des Données de Santé)

This services include the following : Project launch : assistance in framing the project, particularly in identifying and implementing regulatory procedures ; establishment of contacts with relevant stakeholders ; support in collaborating with bodies in charge of health data, particularly with regards to contracting and meeting technical prerequisites for using such data ; Support towards institutional actors, particularly when several data sources are involved and need to be combined or synchronized ; Data handling : support for data custodians in extracting, structuring, qualifying, documenting, standardizing and/or transferring data involved as part of the project ; Support to research implementation : provision of technological capabilities (dedicated project spaces with computing resources for 3 years, state of the art data management, analysis and visualization tools, alongside user onboarding and ongoing technical support), expert support (medical, legal, data scientist, engineer, etc.), training and networking ; Results and project valorization : communication events, networking within the ecosystem, etc. Catalogue database fee : manages the fees related to accessing and utilizing electronic health data for secondary use. The coverage is partial and depends on the chosen database, including standard access fees to database holders, potential compensation for a portion of the data collection costs, and a specific fee covering human and technical resources expended in enriching the electronic health data.

Health Data Hub (Plateforme des Données de Santé)

This services include the following : Project launch : assistance in framing the project, particularly in identifying and implementing regulatory procedures ; establishment of contacts with relevant stakeholders ; support in collaborating with bodies in charge of health data, particularly with regards to contracting and meeting technical prerequisites for using such data ; Support towards institutional actors, particularly when several data sources are involved and need to be combined or synchronized ; Data handling : support for data custodians in extracting, structuring, qualifying, documenting, standardizing and/or transferring data involved as part of the project ; Support to research implementation : provision of technological capabilities (dedicated project spaces with computing resources for 3 years, state of the art data management, analysis and visualization tools, alongside user onboarding and ongoing technical support), expert support (medical, legal, data scientist, engineer, etc.), training and networking ; Results and project valorization : communication events, networking within the ecosystem, etc. Catalogue database fee : manages the fees related to accessing and utilizing electronic health data for secondary use. The coverage is partial and depends on the chosen database, including standard access fees to database holders, potential compensation for a portion of the data collection costs, and a specific fee covering human and technical resources expended in enriching the electronic health data.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Help to select and to use advanced deep learning algorithms to create custom and trustworthy AI models for medical image analysis (e.g. classification, segmentation, feature extraction, anomaly localization). Depending on the modality to be processed, we propose advanced deep learning architectures (CNN, LSTM, ViT, etc.) by selecting the best approach for the task to be performed (classification, localisation, segmentation, etc.). Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Challenge : Difficulties in identifying the needs of users, clients, and other stakeholders, particularly regarding the development of AI-based products, to ensure a focus on the right challenges. This service provides support for the activities needed to collect and analyze requirements for the development of an AI-based product (software and hardware). In addition, the service offers support in setting up a technology roadmap with a prioritization of functionalities to be developed. Our strength: Guiding you in gathering requirements, analyzing needs, and technological guidance to steer future development by applying co-creation and co-innovation techniques with the assistance of a network of specialized stakeholders. Keywords: Business Analysis

RISE Research Institutes Of Sweden

Method description: Add-on support to the service "AI improvement and development" available at RISE. The service includes support for training, deployment and installation. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural Language Processing, Computer Vision, Machine Learning.

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service is designed to deliver valuable insights into emerging trends in healthcare innovation, tailored to support SMEs in their specific business areas. Keywords: Trends; Market; Technology

Politecnico Di Milano (POLIMI)

Testing of technical specifications and analysis of the outcome in a relevant environment (testing phase before real environment testing). Example: when applicable, tests with healthy users are performed to verify technical functions and usability, before moving to tests with the target population (patients). Keywords: Validation, Usability

Karolinska Institutet (KI)

Comprehensive assessment of healthcare AI startups and SMEs across four readiness dimensions—technical, regulatory, organisational, and market—delivering a prioritised roadmap to close identified gaps. The service includes: Technical Readiness Assessment Evaluation of AI model maturity, data pipeline robustness, validation status, deployment architecture, and scalability for clinical or production environments. Regulatory Readiness Assessment Review of compliance posture against the EU AI Act, MDR requirements, GDPR obligations, and status of ethical approvals. Organisational Readiness Assessment Assessment of team competencies, governance structures, quality management systems, and post-market surveillance capability. Market Readiness Assessment Review of product-market fit, go-to-market strategy, reimbursement pathways, value proposition clarity, and competitive positioning. Gap Analysis & Roadmap Structured mapping of gaps between current and target state across all dimensions, with prioritised recommendations, indicative timelines, and a follow-up session.

RISE Research Institutes Of Sweden

Methods description: The service of testing and validation of AI solutions with Deep Learning paradigms. The service can include suggestions of applications and highlight strengths, weaknesses, threats and/or opportunities. The service is customized according to the SME's needs. Pre-requisites for the service are the analysis of data availability, data-readiness level and customer needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated Learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

This module assesses whether the uncertainty estimates provided by an AI model are well-calibrated, meaningful, and suitable for supporting safe decision-making in clinical or high-stakes contexts. The customer-provided model's uncertainty outputs (e.g., confidence scores, predictive distributions, epistemic/aleatoric uncertainty estimates) are evaluated for calibration, sharpness, and reliability. Evaluation can be performed with or without ground truth labels, depending on availability: • With ground truths: Direct assessment of uncertainty quality can be conducted by evaluating how well uncertainty scores align with truly uncertain outcomes. This includes analysis on real out-of-distribution (OOD) samples and ambiguous cases (e.g., annotator disagreement), enabling a precise evaluation of whether high uncertainty corresponds to genuinely difficult or uncertain predictions. • Without ground truths: Proxy tasks can be employed to assess uncertainty quantification capabilities, including synthetic out-of-distribution sample generation, Expected Calibration Error (ECE), Prediction Rejection Ratio (PRR) analysis, and correctness prediction assessment. While less direct, these approaches still provide meaningful insights into model uncertainty quality. Evaluation Outcomes: Positive Indicators • Well-calibrated confidence scores (predicted probabilities reflect true outcome frequencies) • Appropriate uncertainty increases for ambiguous, atypical, or out-of-distribution inputs • Meaningful separation between epistemic and aleatoric uncertainty (if applicable) Negative Indicators • Overconfident predictions on uncertain or out-of-distribution cases • Poorly calibrated probability estimates • Uncertainty scores that do not correlate with prediction errors

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Support iterative process of usability of the medical device prototype for CE mark. Includes the definition/revision of inputs for the usability specification according to the available documentation: - the intended use of the medical device - the risk analysis linked to usability - use scenarios Depending the SME needs, this service may be: - an expert evaluation by an ergonomist or; - support on protocol writing for formative evaluation. The proposed method is based on a user-centered procedure, as described in ISO 9241-210 on the ergonomics of human-system interaction, and complies with ISO 62366-1/ ISO 62366-2 on the usability of medical devices. Keywords: Usability test, Formative evaluation, Summative evaluation

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

User interface evaluation is conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors. The usability testing focuses on the user experience with the device, including the device's graphical user interface (GUI). While a formative usability test goal is to identify and correct any usability problems before the device design is finalized, a summative usability testing intends to generate evidence that a final product that is not only functional but also intuitive and enjoyable to use, leading to increased user satisfaction and loyalty. IPN is able to provide support in a two-step approach: • Study Documents & Submission Process, supporting the preparation of the mandatory documents and the submission of study to the Regulatory Authorities (ethics committees); • Study Conduction & Data Management, supporting the Site Initiation activities, recruitment process, data collection/analysis according to good clinical practices and report

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

This module evaluates whether AI-generated explanations and outputs are understandable, usable, and actionable for the intended human stakeholders (e.g., clinicians, radiologists, patients). The module examines usability, perceived fairness, responsibility & control (human vs. AI), cognitive load, and the emotional and ethical impact of AI in the clinical context. Method Description The evaluation employs established usability and human-centered AI methods, which may include: • Heuristic evaluation: Expert review of AI interfaces against usability, user experience & design principles • Cognitive walkthrough: Task-based analysis of how users would interpret and act on AI outputs (e.g. at critical decision points, including situations where human and AI recommendations diverge) • User studies (optional, scope-dependent): Structured interviews, think-aloud protocols, or questionnaire-based assessment with representative end users to capture variables like understanding, trust, and perceived fairness. • Quantitative measurements: Trust and workload assessments to quantify trust calibration and cognitive load. • Scenario-based evaluation of clinical workflows for edge cases and high-risk situations, to assess human oversight and potential over-/under-reliance on AI • Workshops (optional, scope-dependent): Value- and risk-focused workshop with different stakeholders to investigate risks, and requirements for human oversight. The specific methods applied are tailored to the customer's use case, user groups, and available resources. Evaluation Outcomes Positive Indicators • Explanation quality: Explanations are comprehensible to the intended user group without requiring AI expertise. Users can appropriately calibrate trust based on provided explanations. Explanation format and complexity match clinical workflow requirements • Roles and responsibilities between humans and the AI system are clearly understood and accepted by users • Users perceive the systems behaviour and explanations as fair and aligned with clinical values and ethical standards Negative Indicators • Explanation quality: Explanations are misleading, overly technical, or ambiguous. Users misinterpret explanations or develop inappropriate trust/distrust. Explanation presentation disrupts clinical workflow or decision-making • Unclear responsibility between human and AI leads to uncertainty in high-stakes decisions or error handling • AI is perceived as biased or unfair toward certain patient groups • Increased stress, uncertainty, or ethical issues among clinicians or patients due to the AI system This service is delivered by Fraunhofer HHI as a TEF-Health partner. Fraunhofer HHI provides: • Dedicated compute infrastructure • In-house proprietary XAI and evaluation software • Expert scientific and technical support across all evaluation modules

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN team is able to support the companies planning the iterative process where usability tests are carried out, finding the users and the usability scenario(s)/environment(s) and, if needed, the clinical researchers to conduct the testing in order to ensure that the solution usability is designed so that use-related risks are decreased, and safety increased.

CEED - Charité Healthcare Services GmbH

Our workplace and workflow analyses provide insights into the workflows and environments within the clinic, including the analysis of processes, the physical work environment, and the interaction with other devices and technologies. They can also be used to examine workflows and challenges with existing products. Workplace analyses are crucial for understanding the requirements for designing and integrating new products, ensuring that they can be seamlessly incorporated into existing workflows, taking into account user needs as well as safety and efficiency standards. Keywords:Workplace Analyses, Workflow Analyses, Process Analyses, User and Clinical Requirements, Usability Engineering