TheArtOfService
Cross-Framework Mapping

ISO 27005vsISO 13485

See exactly how ISO 27005 controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
29
Gaps Found
15%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 27005 maps to ISO 13485 with 15% coverage across 6 directly mapped controls. Analysis of 40 ISO 27005 controls identifies 34 compliance gaps — primarily concentrated in Risk Assessment.

Source: TheArtOfService Knowledge Graph | 40 controls analysed | 700 frameworks | 323K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 323K+ mappings across 700 frameworks.

Risk Assessment(3 mappings)

7.1Cyber Incident Response Planning3 targets
→4.1Password Policy
→4.2Multi-Factor Authentication
→8.5Control effectiveness review

Risk Treatment(3 mappings)

8.5Control effectiveness review3 targets
→4.1Password Policy
→4.2Multi-Factor Authentication
→7.1Cyber Incident Response Planning

Communication(2 mappings)

9.1Risk communication and consultation2 targets
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-16Transmission security and encryption

ISO 27005: Risk Assessment(3 mappings)

ISO27005-06Risk identification methods
→ISO13485-06Security management process and risk analysis
ISO27005-08Risk criteria and thresholds
→ISO13485-06Security management process and risk analysis
ISO27005-10Risk interdependency analysis
→ISO13485-06Security management process and risk analysis

Related Comparisons

Other ISO 27005 comparisons

ISO 27005 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements11 mappingsISO 27005 vs AS9100D - Aerospace Quality Management System11 mappingsISO 27005 vs ISO/IEC 27003:201711 mappingsISO 27005 vs AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence10 mappingsISO 27005 vs PIC/S Guide to Good Manufacturing Practice for Medicinal Products8 mappingsISO 27005 vs NIST SP 800-398 mappingsISO 27005 vs NIST SP 800-378 mappingsISO 27005 vs NIST SP 800-308 mappings

Other ISO 13485 comparisons

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO 1348516 mappingsNIST SP 800-66 vs ISO 1348513 mappingsMDS2 (Medical Device) vs ISO 1348513 mappingsMARS-E vs ISO 1348513 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs ISO 1348513 mappingsISO 27799 vs ISO 1348513 mappingsNIST Privacy Framework vs ISO 1348512 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs ISO 1348512 mappings

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What are the key differences between ISO 27005 and ISO 13485?

ISO 27005 has 40 controls across its framework, while ISO 13485 covers 44 controls. Direct mapping analysis identifies 6 overlapping controls (15% coverage). The frameworks diverge most significantly in Risk Assessment, where 7 ISO 27005 controls have no direct ISO 13485 equivalent.

How many controls map between ISO 27005 and ISO 13485?

Of 40 total ISO 27005 controls, 6 map directly to ISO 13485 controls — representing 15% coverage. The remaining 34 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 27005 to ISO 13485?

34 ISO 27005 controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in Risk Assessment with 7 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 27005 and ISO 13485?

The domain with the highest gap count is Risk Assessment (7 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.