TheArtOfService
Cross-Framework Mapping

MDS2 (Medical Device)vsFDA 21 CFR Part 11

See exactly how MDS2 (Medical Device) controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

25
Controls Mapped
0
Gaps Found
42%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

MDS2 (Medical Device) maps to FDA 21 CFR Part 11 with 42% coverage across 10 directly mapped controls. Analysis of 24 MDS2 (Medical Device) controls identifies 14 compliance gaps — primarily concentrated in MDS2 (Medical Device): Organizational Requirements.

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

Control Mappings

Showing 20 of 25 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

MDS2 (Medical Device): Patient Data Protection(13 mappings)

MDS2-01ePHI access controls and authorization6 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
MDS2-02ePHI encryption at rest and in transit4 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
→FDA-CFR11-16Transmission security and encryption
MDS2-05Audit 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

MDS2 (Medical Device): Administrative Safeguards(6 mappings)

MDS2-06Security management process and risk analysis
→FDA-CFR11-06Security management process and risk analysis
MDS2-07Workforce security and clearance procedures
→FDA-CFR11-07Workforce security and clearance procedures
MDS2-08Information access management3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
MDS2-09Security awareness and training program
→FDA-CFR11-09Security awareness and training program

MDS2 (Medical Device): Technical Safeguards(1 mappings)

MDS2-12Unique user identification and authentication
→FDA-CFR11-12Unique user identification and authentication

+5 more mappings

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Related Comparisons

Other MDS2 (Medical Device) comparisons

MDS2 (Medical Device) vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule11 mappingsMDS2 (Medical Device) vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements10 mappingsMDS2 (Medical Device) vs GLI-33 — Gaming Laboratories International Event Wagering Systems10 mappingsMDS2 (Medical Device) vs TISAX — Trusted Information Security Assessment Exchange10 mappingsMDS2 (Medical Device) vs HIPAA Security Rule10 mappingsMDS2 (Medical Device) vs ISO 1348510 mappingsMDS2 (Medical Device) vs NYDFS Cybersecurity Regulation (23 NYCRR Part 500)10 mappingsMDS2 (Medical Device) vs ISO 2779910 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 mappingsISO 13485 vs FDA 21 CFR Part 1111 mappingsGLI-33 — Gaming Laboratories International Event Wagering Systems vs FDA 21 CFR Part 1111 mappings

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What are the key differences between MDS2 (Medical Device) and FDA 21 CFR Part 11?

MDS2 (Medical Device) has 24 controls across its framework, while FDA 21 CFR Part 11 covers 24 controls. Direct mapping analysis identifies 10 overlapping controls (42% coverage). The frameworks diverge most significantly in MDS2 (Medical Device): Organizational Requirements, where 4 MDS2 (Medical Device) controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between MDS2 (Medical Device) and FDA 21 CFR Part 11?

Of 24 total MDS2 (Medical Device) controls, 10 map directly to FDA 21 CFR Part 11 controls — representing 42% coverage. The remaining 14 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping MDS2 (Medical Device) to FDA 21 CFR Part 11?

14 MDS2 (Medical Device) controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in MDS2 (Medical Device): 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 MDS2 (Medical Device) and FDA 21 CFR Part 11?

The domain with the highest gap count is MDS2 (Medical Device): 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.