Regulatory Affairs for Digital Health & AI Medical Devices
Regulatory Affairs for Digital Health & AI Medical Devices
EU MDR, FDA & AI Medical Devices: SaMD compliance, technical file, GSPR, cybersecurity & audit-ready checklists
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What you'll learn
- Define Digital Health, SaMD and AIaMD—and set intended use and claims that align with regulatory expectations (EU/US)
- Decide if your software is a medical device using practical qualification logic for EU MDR/IVDR and US FDA pathways
- Classify medical device software under EU MDR/IVDR (including Rule 11 pitfalls) and choose the right conformity route
- Build an EU MDR technical file for software: architecture, risk, V&V, clinical evidence, labeling, and traceability
- Create a robust GSPR mapping: link every Annex I requirement to evidence without gaps (audit-friendly and reviewer-ready)
- Plan clinical and performance evidence for SaMD/AI: validation structure, clinical relevance, and RWE positioning
- Apply cybersecurity-by-design: threat modeling, SBOM basics, security testing, vulnerability handling, and documentation
- Run a “minimum viable QMS” and regulated software lifecycle: change control, versioning, release management, CAPA
- Use final EU/US readiness checklists to prepare for Notified Body audits and FDA pre-submissions/submissions
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