This list includes global regulations that USDM supports for our life sciences customers along with a link to the regulation for more information.*
We pride ourselves on staying current with the global regulatory landscape and are consistently at the forefront of driving change to keep up with technology.
Regulatory coverage at a glance
- FDA frameworks: 21 CFR Part 11, Part 210/211 (cGMP), Part 820 (QSR/QMSR), Part 50/56 (clinical), Part 211.
- EU frameworks: EU MDR/IVDR, EU GMP Annex 11, EU Annex 1, GDPR for life sciences data.
- Global standards: ICH guidelines (Q7-Q12, E6 GCP), ISO 13485, ISO 14971, ISO 27001.
- Country-specific: PMDA (Japan), Health Canada, TGA (Australia), ANVISA (Brazil), and others.
Good Clinical Practices
- 21 CFR Part 11
- 21 CFR Par5 50
- 21 CFR Part 54
- 21 CFR Part 56
- 21 CFR Part 312
- 21 CFR Part 314
- Part 807 Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
- 21 CFR Part 812 – Investigational Device Exemptions
- 21 CFR Part 814 – Premarket Approval of Medical Device
- The 510k & Premarket Approval (PMA) Guidance Document
- ICH E2A
- ICH E6 (R2)
GMP International Reference Guide
- 21 CFR Part 11
- Part 58 GLP
- Part 111 Dietary Supplement GMPs
- Part 210 Drug GMPs
- Part 211 Drug GMPs
- Part 820 Quality System Regulations
- ICH Q7 active Pharmaceutical Agreements
- ICH Q8 Pharmaceutical Development
- ICH Q9 Quality Risk Management (Guidance for Industry-FDA)
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- ICH Q11 Development and Manufacture of Drug Substances
- ICH Q12 Pharmaceutical Product Lifecycle Management (Draft)
- EU GMPs
- Canadian GMPs
- Japanese GMPs
- Australian GMPs
GMP Medical Device Reference Guide
- 21 CFR Part 11
- Part 801 Labeling
- Part 803 Reporting
- Part 806 Corrections and Removals
- Part 807 Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
- 21 CFR Part 809 In-Vitro Diagnostic Products
- 21 CFR Part 810 – Medical Device Recall Authority
- 21 CFR Part 812 – Investigational Device Exemptions
- 21 CFR Part 814 – Premarket Approval of Medical Device
- Part 820 Quality System Regulations
- 21 CFR Part 821 – Medical Device Tracking Requirements
- 21 CFR Part 822 – Postmarket Surveillance
- 21 CFR Part 830 – Unique Device Identification
- Medical Device QSIT Manual
- PMA Premarket Approval and 510 (k) Guidance
- Inspection of Medical Device Manufacturers Program 7382.845
- Annex 11 Computerized Systems
- Annex 15 Qualification and Validation
- ICH Q9 Quality Risk Management (Guidance for Industry-FDA)
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System
- Canadian Medical Device Regulations – SOR/98-282
- ISO 13485 Quality Systems (Canadian Guidelines)
- 98/79/EC In Vitro Diagnostic Medical Devices
- 93/42/EEC Medical Device Directive Updated 2007/47/EC September 2007
*This is not an exhaustive list; for guidance on a regulation that is not listed, please contact usdm@usdm.com
FAQ: Supported Regulations
Which regulations does USDM Cloud Assurance support?
USDM supports the major global life sciences frameworks including FDA (Part 11, cGMP, QMSR), EU (MDR/IVDR, Annex 11), ICH, ISO standards, and country-specific regulations across pharma, biotech, and medical devices.
Are regulations updated as they change?
Yes. USDM continuously monitors regulatory updates and incorporates changes into Cloud Assurance frameworks, ensuring customer compliance programs stay current.
How does USDM help?
USDM provides regulatory compliance strategy, framework alignment, and ongoing managed compliance services for life sciences organizations operating globally. Contact USDM.