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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.

  • ISO 13485 (medical device)
  • ISO 14971 & ISO 24971 (medical device)
  • EU MDR 2017/745 QMS (medical device)
  • EU MDR 2017/745 Technical Documentation
  • FDA Labeling & UDI (801 & 830)  (medical device)
  • FDA QMS Core (803, 806, Part 7 & 820)  (medical device) 
  • FDA Part 11  (All FDA, medical device, pharma, etc.)
  • ISO 17025 – Testing and Calibration Laboratories
  • ISO 10993 & FDA Biocompatibility Guidance
  • ISO 9001 (QMS)
  • Health Canada SOR/98-282 – (medical device)
  • HIPAA as a BAA
  • Health Canada Machine Learning in Medical Device Guidance
  • 21 CFR 801 – Labeling
  • 21 CFR 803 – Medical Device Reporting
  • 21 CFR 806 – Reports of Corrections and Removals
  • EU 536:2014
  • ICH Q10 – Pharmaceutical Quality System (Pharma)
  • 21 CFR 58 – GLP for Nonclinical Lab studies
  • 21 CFR 50 (Clinical) 

Coming in April/May

  • ICH E8 – General Considerations for Clinical Trials
  • ICH Q1 –  Stability
  • ICH Q2 – Analytical Validation
  • ICH Q3 – Impurities
  • ICH Q6 – Specifications
  • ICH Q7 (Pharma)
  • ICH Q9 – GMP

  • FDA premarket software guidance (medical device)
  • FDA premarket cybersecurity guidance (medical device)
  • FDA postmarket cybersecurity guidance (medical device)
  • EU & UK GDPR
  • IEC 27001 cybersecurity
  • ICH E6(R3) for Investigators  (clinical, pharma)
  • ICH E6(R3) for Sponsors (CRO)  (clinical, pharma)
  • 21 CFR 210 & 21 CFR 211 (pharma)
  • UK MDR 2002 (medical device)
  • IEC 82304-1 (medical device, software)
  • EU 2017/1572 (Pharma)
  • EU 2001/83/EC (Pharma)
  • UK Data Protection Act 2018 (All industries)
  • UK CTR – Clinical Trials (All industries)
  • 21 CFR 820 (medical device)
  • IEC 62366 (medical device)
  • Directive 95/46/EC (CTR) (All industries)
  • 21 CFR 4 – Regulations of Combinational Products
  • 21 CFR 600 (Biologics)
  • 21 CFR 610 (Biologics)

Coming Soon (June Onward)

  • ICH Q8 (Pharma)
  • ICH Q4 (Pharma)
  • ICH Q5 (Pharma)
  • 21 CFR 807 (Medical Device)
  • ICH Q11 (Pharma)
  • ICH Q12 (Pharma)
  • EudraLex Volume 4 Annex 11
  • EudraLex Volume 4 Annex 16
  • 21 CFR 7 (All industries)
  • 21 CFR 54 (Clinical)
  • 21 CFR 56 (IRBs) (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 56 (Clinical)
  • 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 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)