AI Readiness Review: Evaluating Your Pipeline and Documentation
Service Description
Overview
This service provides a structured evaluation of AI development pipelines and technical documentation, tailored for SMEs and researchers in healthtech. Leveraging clinical and regulatory expertise at SMAILE, Karolinska Institutet, the assessment covers traceability, software versioning, model lifecycle management, and documentation practices. The process ensures that development pipelines meet regulatory expectations, reproducibility requirements, and are aligned with future audit or MDR/AI Act evaluations.
We provide expertise and support in:
- AI documentation & pipeline evaluation
- MDR readiness & traceability compliance
How can the service help you?
This service addresses the lack of clear documentation and reproducible workflows in early-stage AI development. It gives you a clear roadmap for improvement and regulatory preparedness. Whether you're pursuing CE marking or preparing for due diligence from investors, this service boosts your confidence and credibility.
How the service will be delivered?
Delivered virtually by SMAILE experts at Karolinska Institutet. Includes documentation review and remote interviews. Typically executed over 1–3 weeks.
Additional information
Provider description
The SMAILE core facility at Karolinska Institutet offers expert consulting and virtual testing for AI system validation, regulatory preparation, biomedical signal analysis, and data-driven life science solutions. SMAILE collaborates across KI, SciLifeLab, and RISE under the Swedish TEF-Health node.
Technical description
The service includes a structured audit of AI development stages using a checklist of regulatory, technical, and reproducibility indicators. The pipeline’s documentation is reviewed, highlighting gaps and providing targeted improvement suggestions.
Service customization
The scope can be tailored to specific pipeline stages (e.g., pre-processing, model training, evaluation). Clients may combine this service with model benchmarking or regulatory consultation.
Provider & Contact
Prices are indicative only and can change depending upon clinical expertise requirements (and affiliation); this service can be subsidised up to 100%. Additional data storage and handling costs can be added separately according to project requirements and SME needs. The average personnel cost is 115 EUR per hour (depending upon affiliation, personnel costs can be up to 100% subsidised).
Example price for a 200-hour project (including consultancy with a clinical expert, project management, data assembly and cleaning processes). Data storage is not included in this price). Full price: 23 000 EUR, Reduced price: 2 300 EUR (subsidisation of 90%, based on case study).