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.
- ISO 13485:2016 (device)
- ISO 14971:2019 & ISO 24971:2020 (device)
- EU MDR 2017/745 QMS (device)
- FDA Labeling & UDI (801 & 830) (device)
- FDA QMS Core (803, 806, Part 7 & 820) (device)
- FDA Part 11 (All FDA, device, pharma, etc.)
- ISO 17025
- ISO 10993 & FDA Biocompatibility Guidance
- ISO 9001
- EU MDR 2017/745 QMS
- EU MDR 2017/745 Technical Documentation
- Health Canada SOR/98-282
- HIPAA as a BAA
- Health Canada Machine Learning in Medical Device Guidance
- 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 82304-1:2016 (medical device, software)