Below is an overview of the regulations, guidance documents & standards in the AI assessment scope. Note: If one you need is not listed, please immediately tell us.

1. ISO 13485 (medical device)
2. ISO 14971 & ISO 24971 (medical device)
3. EU MDR 2017/745 QMS (medical device)
4. FDA Labeling & UDI (801 & 830)  (medical device)
5. FDA QMS Core (803, 806, Part 7 & 820)  (medical device) 
6. FDA Part 11  (All FDA, medical 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 (medical device, software)
25. EU 2017/1572 (Pharma)
26. EU 2001/83/EC (Pharma)
27. UK Data Protection Act 2018 (All industries)

Coming Soon

1. EU Directive 2001/20/EC (Pharma)
2. EU 536/2014 (Pharma)
3. 21 CFR 812 (Clinical Investigations)
4. MDSAP – Australia TGA Schedule 3, Part 1 of MDR 2002 (Medical Device)
5. MDSAP – Brazil RDC ANVISA 665/2022 (Medical Device)
6. MDSAP – Japan MHLW MO169 (Medical Device)
7. MDSAP – South Korea MFDS Notice No. 2025-22 (Medical Device)
8. EU AI Act (All industries with AI)
9. 21 CFR 600 (Biologics)
10. 21 CFR 610 (Biologics)
11. ISPE Gamp 5 (Pharma)
12. ICH Q7 (Pharma)
13. 21 CFR 201 (Pharma)
14. 21 CFR 50 & 56 (Clinical)
15. 21 CFR 202 & 203 (Pharma)
16. FDA Predetermined Change Control Plan (PCCP) (Medical Device)