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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.

Live

  1. ISO 13485 (medical device)
  2. ISO 14971 & ISO 24971 (medical device)
  3. EU MDR 2017/745 QMS (medical device)
  4. EU MDR 2017/745 Technical Documentation
  5. FDA Labeling & UDI (21 CFR 801 & 830)  (medical device)
  6. FDA QMS Core (803, 806, Part 7 & 820)  (medical device) 
  7. FDA Part 11  (All FDA, medical device, pharma, etc.)
  8. ISO 17025 – Testing and Calibration Laboratories
  9. ISO 10993 & FDA Biocompatibility Guidance
  10. ISO 9001 (QMS)
  11. Health Canada SOR/98-282 – (medical device)
  12. HIPAA as a BAA
  13. Health Canada Machine Learning in Medical Device Guidance
  14. 21 CFR 803 – Medical Device Reporting
  15. 21 CFR 806 – Reports of Corrections and Removals
  16. EU 536:2014
  17. ICH Q10 – Pharmaceutical Quality System (Pharma)
  18. 21 CFR 58 – GLP for Nonclinical Lab studies
  19. 21 CFR 50 (Clinical) 
  20. 21 CFR 56 (IRBs) (Clinical)
  21. ICH Q3 – Impurities
  22. EudraLex Volume 4
  23. EudraLex Volume 4 Annex 2
  24. MHLW MO No.136 (GMP)
  25. MHLW MO No.179 (GMP)
  26. EudraLex Volume 4 Annex 1
  27. 21 CFR 807 (Medical Device)
  28. 21 CFR 312 – Investigational New Drug (IND) Application (Pharma/Clinical)
  29. ICH Q5 (Pharma)
  30. ICH Q12 (Pharma)
  31. ICH Q4 (Pharma)
  32. FDA premarket software guidance (medical device)
  33. FDA premarket cybersecurity guidance (medical device)
  34. FDA postmarket cybersecurity guidance (medical device)
  35. EU & UK GDPR
  36. IEC 27001 cybersecurity
  37. ICH E6(R3) for Investigators  (clinical, pharma)
  38. ICH E6(R3) for Sponsors (CRO)  (clinical, pharma)
  39. 21 CFR 210 & 21 CFR 211 (pharma)
  40. UK MDR 2002 (medical device)
  41. IEC 82304-1 (medical device, software)
  42. EU 2017/1572 (Pharma)
  43. EU 2001/83/EC (Pharma)
  44. UK Data Protection Act 2018 (All industries)
  45. UK CTR – Clinical Trials (All industries)
  46. 21 CFR 820 (medical device)
  47. IEC 62366 (medical device)
  48. Directive 95/46/EC (CTR) (All industries)
  49. 21 CFR 4 – Regulations of Combinational Products
  50. 21 CFR 600 (Biologics)
  51. 21 CFR 610 (Biologics)
  52. ICH Q6 – Specifications
  53. ICH Q7 (Pharma)
  54. ICH Q1 –  Stability
  55. ICH E8 – General Considerations for Clinical Trials
  56. ICH Q11 (Pharma)
  57. WHO Annex 4
  58. UK Government Guidelines for AI in Healthcare
  59. ICH Q9 – GMP
  60. ICH E2
  61. EudraLex Volume 4 Annex 16
  62. FDA Guidance on Pharmaceutical CGMP
  63. EudraLex Volume 4 Annex 11
  64. PMDA Guidance on Aseptic Processing (Japan)

    Coming Soon

    • ICH Q8 (Pharma)
    • ICH Q2 – Analytical Validation
    • 21 CFR 7 (All industries)
    • 21 CFR 54 (Clinical)
    • 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)
    • ISPE Gamp 5 (Pharma)
    • 21 CFR 201 (Pharma)
    • 21 CFR 202 & 203 (Pharma)
    • FDA Predetermined Change Control Plan (PCCP) (Medical Device)
    • 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 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)