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Current Regulations

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

  • EU Directive 2001/20/EC (Pharma)
  • EU 536/2014 (Pharma)
  • 21 CFR 812 (Clinical Investigations)
  • MDSAP – Australia TGA Schedule 3, Part 1 of MDR 2002 (Medical Device)
  • MDSAP – Brazil RDC ANVISA 665/2022 (Medical Device)
  • MDSAP – Japan MHLW MO169 (Medical Device)
  • MDSAP – South Korea MFDS Notice No. 2025-22 (Medical Device)
  • EU AI Act (All industries with AI)
  • 21 CFR 600 (Biologics)
  • 21 CFR 610 (Biologics)
  • ISPE Gamp 5 (Pharma)
  • ICH Q7 (Pharma)
  • 21 CFR 201 (Pharma)
  • 21 CFR 50 & 56 (Clinical)
  • 21 CFR 202 & 203 (Pharma)
  • FDA Predetermined Change Control Plan (PCCP) (Medical Device)
  • ICH Q10 – Pharmaceutical Quality System (Pharma)
  • EU GMP Chapter 7 – Outsourced Activities (Pharma)
  • PIC/S PI 041-1 – Good Practices for Data Management and Integrity (Pharma)
  • IPEC GMP / EXCiPACT – Excipient Supplier Standards (Pharma)
  • GDP (EU 2013/C 343/01) – Good Distribution Practice (Pharma)
  • 21 CFR 54 – Financial Disclosure by Clinical Investigators (Clinical)
  • 45 CFR 46 (OHRP) – Protection of Human Subjects (Common Rule) (Clinical)
  • 21 CFR 312 – Investigational New Drug (IND) Application (Pharma/Clinical)
  • 21 CFR 314 – Applications for FDA Approval to Market a New Drug (NDA) (Pharma)
  • 21 CFR 320 – Bioavailability and Bioequivalence Requirements (Pharma)
  • 21 CFR 361.1 – Radioactive Drugs for Certain Research Uses (Pharma/Clinical)
  • 21 CFR 601 – Licensing (Biological Licensing Applications – BLA) (Biologics)
  • 21 CFR 607 – Establishment Registration for Blood and Blood Products (Biologics)
  • 21 CFR 630 – Requirements for Blood and Blood Components (Biologics)
  • 21 CFR 640 – Additional Standards for Human Blood and Blood Products (Biologics)21 CFR 660 – Additional Standards for Diagnostic Substances for Laboratory Tests (Biologics)
  • 21 CFR 680 – Additional Standards for Miscellaneous Products (Biologics)
  • 21 CFR 814 – Premarket Approval of Medical Devices (PMA) (Medical Device)
  • 21 CFR 4 – Current Good Manufacturing Practice Requirements for Combination Products (Combination Products)
  • 21 CFR 58 – Good Laboratory Practice for Nonclinical Laboratory Studies (Nonclinical/GLP)
  • 21 CFR 606 – Current Good Manufacturing Practice for Blood and Blood Components (Biologics)
  • 21 CFR 1271 – Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Biologics/Advanced Therapies)
  • 42 CFR 11 – Clinical Trials Registration and Results Information Submission (Clinical)
  • 21 CFR 70 – Color Additives (Excipients/Food)
  • 21 CFR 71 – Color Additives Petitions (Excipients/Food)
  • 21 CFR 74 – Listing of Color Additives Subject to Certification (Excipients/Food)
  • 21 CFR 80 – Color Additive Certification (Excipients/Food)
  • 21 CFR 82 – Listing of Certified Provisionally Listed Colors (Excipients/Food)
  • 21 CFR 101 – Food Labeling (Food/Dietary Supplements)
  • 21 CFR 107 – Infant Formula (Food)
  • 21 CFR 170 – Food Additives (Food)
  • 21 CFR 180 – Food Additives Permitted in Food on Interim Basis (Food)
  • 21 CFR 190 – Dietary Supplements (Dietary Supplements)
  • 21 CFR 570 – Food Additives (General) (Food)
  • 21 CFR 310 – New Drugs (Post market) (Pharma)
  • 21 CFR 329 – Nonprescription Human Drug Products Subject to Section 760 (Pharma/OTC)
  • FD&C Act Section 355 (21 U.S.C. 355) – New Drugs (Pharma/Statutory)FD&C Act Section 379aa (21 U.S.C. 379aa) – Serious Adverse Event Reporting for OTC (Pharma/Statutory)