Current Regulations

Below is an overview of the regulations, guidance documents & standards in the AI assessment scope. Targeting 50 assessments by the end of 2025.

  1. ISO 13485:2016 (device)
  2. ISO 14971:2019 & ISO 24971:2020 (device)
  3. EU MDR 2017/745 QMS (device)
  4. FDA Labeling & UDI (801 & 830)  (device)
  5. FDA QMS Core (803, 806, Part 7 & 820)  (device) 
  6. FDA Part 11  (All FDA, device, pharma, etc.)
  7. ISO 17025 
  8. ISO 10993 & FDA Biocompatibility Guidance
  9. ISO 9001 
  10. EU MDR 2017/745 QMS
  11. EU MDR 2017/745 Technical Documentation
  12. Health Canada SOR/98-282
  13. HIPAA as a BAA
  14. Health Canada Machine Learning in Medical Device Guidance
  15. FDA premarket software guidance (medical device)
  16. FDA premarket cybersecurity guidance (medical device)
  17. FDA postmarket cybersecurity guidance (medical device)
  18. EU & UK GDPR
  19. IEC 27001 cybersecurity
  20. ICH E6(R3) for Investigators  (clinical, pharma)
  21. ICH E6(R3) for Sponsors (CRO)  (clinical, pharma)
  22. 21 CFR 210 & 21 CFR 211 (pharma)
  23. UK MDR 2002 (medical device)
  24. IEC 82304-1:2016 (medical device, software)