TheArtOfService
Cross-Framework Mapping

ISO 13485vsFDA 21 CFR Part 11

See exactly how ISO 13485 controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

26
Controls Mapped
0
Gaps Found
50%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to FDA 21 CFR Part 11 with 50% coverage across 12 directly mapped controls. Analysis of 24 ISO 13485 controls identifies 12 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.

Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 20 of 26 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

ISO 13485: Patient Data Protection(14 mappings)

ISO13485-01ePHI access controls and authorization3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
ISO13485-02ePHI encryption at rest and in transit2 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-16Transmission security and encryption
ISO13485-03Minimum necessary standard enforcement3 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
ISO13485-04Patient data de-identification procedures3 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
ISO13485-05Audit trail for ePHI access3 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access

ISO 13485: Administrative Safeguards(6 mappings)

ISO13485-06Security management process and risk analysis
→FDA-CFR11-06Security management process and risk analysis
ISO13485-07Workforce security and clearance procedures
→FDA-CFR11-07Workforce security and clearance procedures
ISO13485-08Information access management3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
ISO13485-09Security awareness and training program
→FDA-CFR11-09Security awareness and training program

+6 more mappings

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Related Comparisons

Other ISO 13485 comparisons

ISO 13485 vs NIS2 Directive Implementing Acts12 mappingsISO 13485 vs UK Telecommunications (Security) Act 202112 mappingsISO 13485 vs GLI-33 — Gaming Laboratories International Event Wagering Systems12 mappingsISO 13485 vs TISAX — Trusted Information Security Assessment Exchange12 mappingsISO 13485 vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule12 mappingsISO 13485 vs MDS2 (Medical Device)12 mappingsISO 13485 vs ISO 2779912 mappingsISO 13485 vs MARS-E12 mappings

Other FDA 21 CFR Part 11 comparisons

NIS2 Directive Implementing Acts vs FDA 21 CFR Part 1111 mappingsUK Telecommunications (Security) Act 2021 vs FDA 21 CFR Part 1111 mappingsUS Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule vs FDA 21 CFR Part 1111 mappingsNIST SP 800-66 vs FDA 21 CFR Part 1111 mappingsTISAX — Trusted Information Security Assessment Exchange vs FDA 21 CFR Part 1111 mappingsISO 27799 vs FDA 21 CFR Part 1111 mappingsGLI-33 — Gaming Laboratories International Event Wagering Systems vs FDA 21 CFR Part 1111 mappingsMDS2 (Medical Device) vs FDA 21 CFR Part 1111 mappings

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What are the key differences between ISO 13485 and FDA 21 CFR Part 11?

ISO 13485 has 24 controls across its framework, while FDA 21 CFR Part 11 covers 24 controls. Direct mapping analysis identifies 12 overlapping controls (50% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between ISO 13485 and FDA 21 CFR Part 11?

Of 24 total ISO 13485 controls, 12 map directly to FDA 21 CFR Part 11 controls — representing 50% coverage. The remaining 12 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 13485 to FDA 21 CFR Part 11?

12 ISO 13485 controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in ISO 13485: Organizational Requirements with 4 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between ISO 13485 and FDA 21 CFR Part 11?

The domain with the highest gap count is ISO 13485: Organizational Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.