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.