Skip to Content
← Back to services

Regulatory Consulting: Person Responsible for Regulatory Compliance

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 000845b3-a8db-4207-b6db-7e1e2ee68da9

Service Description

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).
Offerings: Ethics & Regulatory Affairs Quality Management Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
Provider Country Portugal
Published Email medicaldevices@ipn.pt
Billing: per hour
Full Price €85-150 EUR
Reduced Price €0-120 EUR
Pricing Detail

depending on seniority

Operational Details

Certification Support CE Marking (MDR, IVDR)

Related services

  • AI Algorithm in Medical Robotics

    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

    View service →
  • AI algorithms development and improvement

    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

    View service →
  • AI and Optolectronics Prototype Optimization

    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.

    View service →
  • AI Evaluation

    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

    View service →
  • AI Evaluation Training

    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

    View service →
  • AI improvement and development

    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

    View service →