TheArtOfService
Cross-Framework Mapping

API 1164vsISO 13485

See exactly how API 1164 controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
13
Gaps Found
17%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

API 1164 maps to ISO 13485 with 17% coverage across 4 directly mapped controls. Analysis of 24 API 1164 controls identifies 20 compliance gaps — primarily concentrated in API 1164: Incident Response & Recovery.

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

Control Mappings

Showing 11 of 11 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

API 1164: Access Management(10 mappings)

API1164-06Physical and logical access controls3 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-08Information access management
→ISO13485-17Facility access controls
API1164-07Personnel risk assessment4 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-06Security management process and risk analysis
→ISO13485-08Information access management
→ISO13485-17Facility access controls
API1164-09Interactive remote access security3 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-08Information access management
→ISO13485-17Facility access controls

API 1164: Supply Chain & Configuration(1 mappings)

API1164-24Vulnerability assessment for critical systems
→ISO13485-06Security management process and risk analysis

Related Comparisons

Other API 1164 comparisons

API 1164 vs NIST SP 1800-3216 mappingsAPI 1164 vs ISO 2701916 mappingsAPI 1164 vs DO-326A / ED-202A16 mappingsAPI 1164 vs BIMCO Cyber Security16 mappingsAPI 1164 vs IEC 6244316 mappingsAPI 1164 vs NIS2 Directive16 mappingsAPI 1164 vs IEEE 168616 mappingsAPI 1164 vs C2M216 mappings

Other ISO 13485 comparisons

FDA 21 CFR Part 11 vs ISO 1348512 mappingsNIS2 Directive Implementing Acts vs ISO 1348512 mappingsUK Telecommunications (Security) Act 2021 vs ISO 1348512 mappingsGLI-33 — Gaming Laboratories International Event Wagering Systems vs ISO 1348512 mappingsTISAX — Trusted Information Security Assessment Exchange vs ISO 1348512 mappingsUS Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule vs ISO 1348512 mappingsMDS2 (Medical Device) vs ISO 1348512 mappingsISO 27799 vs ISO 1348512 mappings

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What are the key differences between API 1164 and ISO 13485?

API 1164 has 24 controls across its framework, while ISO 13485 covers 24 controls. Direct mapping analysis identifies 4 overlapping controls (17% coverage). The frameworks diverge most significantly in API 1164: Incident Response & Recovery, where 5 API 1164 controls have no direct ISO 13485 equivalent.

How many controls map between API 1164 and ISO 13485?

Of 24 total API 1164 controls, 4 map directly to ISO 13485 controls — representing 17% coverage. The remaining 20 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping API 1164 to ISO 13485?

20 API 1164 controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in API 1164: Incident Response & Recovery with 5 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 API 1164 and ISO 13485?

The domain with the highest gap count is API 1164: Incident Response & Recovery (5 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.