Cross-Framework Mapping

FDA 21 CFR Part 11vsISO 13485

Name: FDA 21 CFR Part 11 to ISO 13485 Control Mapping Dataset
Creator: TheArtOfService

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

Controls Mapped

Gaps Found

46%

Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to ISO 13485 with 46% coverage across 11 directly mapped controls. Analysis of 24 FDA 21 CFR Part 11 controls identifies 13 compliance gaps — primarily concentrated in FDA 21 CFR Part 11: 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.

FDA 21 CFR Part 11: Patient Data Protection(14 mappings)

FDA-CFR11-01ePHI access controls and authorization3 targets

→ISO13485-01ePHI access controls and authorization

→ISO13485-08Information access management

→ISO13485-17Facility access controls

FDA-CFR11-02ePHI encryption at rest and in transit5 targets

→ISO13485-02ePHI encryption at rest and in transit

→ISO13485-03Minimum necessary standard enforcement

→ISO13485-04Patient data de-identification procedures

→ISO13485-05Audit trail for ePHI access

→ISO13485-16Transmission security and encryption

FDA-CFR11-04Patient data de-identification procedures3 targets

→ISO13485-03Minimum necessary standard enforcement

→ISO13485-04Patient data de-identification procedures

→ISO13485-05Audit trail for ePHI access

FDA-CFR11-05Audit trail for ePHI access3 targets

→ISO13485-03Minimum necessary standard enforcement

→ISO13485-04Patient data de-identification procedures

→ISO13485-05Audit trail for ePHI access

FDA 21 CFR Part 11: Administrative Safeguards(6 mappings)

FDA-CFR11-06Security management process and risk analysis

→ISO13485-06Security management process and risk analysis

FDA-CFR11-07Workforce security and clearance procedures

→ISO13485-07Workforce security and clearance procedures

FDA-CFR11-08Information access management3 targets

→ISO13485-01ePHI access controls and authorization

→ISO13485-08Information access management

→ISO13485-17Facility access controls

FDA-CFR11-09Security awareness and training program

→ISO13485-09Security awareness and training program

+6 more mappings

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Related Comparisons

Other FDA 21 CFR Part 11 comparisons

FDA 21 CFR Part 11 vs NIS2 Directive Implementing Acts11 mappings FDA 21 CFR Part 11 vs UK Telecommunications (Security) Act 202111 mappings FDA 21 CFR Part 11 vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule11 mappings FDA 21 CFR Part 11 vs NIST SP 800-6611 mappings FDA 21 CFR Part 11 vs TISAX — Trusted Information Security Assessment Exchange11 mappings FDA 21 CFR Part 11 vs ISO 2779911 mappings FDA 21 CFR Part 11 vs GLI-33 — Gaming Laboratories International Event Wagering Systems11 mappings FDA 21 CFR Part 11 vs MDS2 (Medical Device)11 mappings

Other ISO 13485 comparisons

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

FDA 21 CFR Part 11 has 24 controls across its framework, while ISO 13485 covers 24 controls. Direct mapping analysis identifies 11 overlapping controls (46% coverage). The frameworks diverge most significantly in FDA 21 CFR Part 11: Organizational Requirements, where 4 FDA 21 CFR Part 11 controls have no direct ISO 13485 equivalent.

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

Of 24 total FDA 21 CFR Part 11 controls, 11 map directly to ISO 13485 controls — representing 46% coverage. The remaining 13 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

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

13 FDA 21 CFR Part 11 controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in FDA 21 CFR Part 11: 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 FDA 21 CFR Part 11 and ISO 13485?

The domain with the highest gap count is FDA 21 CFR Part 11: 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.