TheArtOfService
Cross-Framework Mapping

BSIMMvsISO 13485

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

19
Controls Mapped
12
Gaps Found
26%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

BSIMM maps to ISO 13485 with 26% coverage across 8 directly mapped controls. Analysis of 31 BSIMM controls identifies 23 compliance gaps — primarily concentrated in BSIMM: Communications Security.

Source: TheArtOfService Knowledge Graph | 31 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 19 of 19 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

BSIMM: Access Control(10 mappings)

BSIMM-11Access control policy and enforcement3 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-08Information access management
→ISO13485-17Facility access controls
BSIMM-13Authentication and password management4 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-08Information access management
→ISO13485-12Unique user identification and authentication
→ISO13485-17Facility access controls
BSIMM-14Privileged access management3 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-08Information access management
→ISO13485-17Facility access controls

BSIMM: Cryptography(8 mappings)

BSIMM-17Encryption of data at rest2 targets
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-16Transmission security and encryption
BSIMM-18Encryption of data in transit2 targets
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-16Transmission security and encryption
BSIMM-19Certificate management2 targets
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-16Transmission security and encryption
BSIMM-20Key lifecycle management2 targets
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-16Transmission security and encryption

BSIMM: Operations Security(1 mappings)

BSIMM-24Logging and monitoring
→ISO13485-05Audit trail for ePHI access

Related Comparisons

Other BSIMM comparisons

BSIMM vs OWASP ASVS18 mappingsBSIMM vs 3GPP Security18 mappingsBSIMM vs NIST SP 800-20718 mappingsBSIMM vs SLSA18 mappingsBSIMM vs TISAX — Trusted Information Security Assessment Exchange18 mappingsBSIMM vs NIST SP 800-18318 mappingsBSIMM vs MITRE ATT&CK18 mappingsBSIMM vs OWASP SAMM18 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 BSIMM and ISO 13485?

BSIMM has 31 controls across its framework, while ISO 13485 covers 24 controls. Direct mapping analysis identifies 8 overlapping controls (26% coverage). The frameworks diverge most significantly in BSIMM: Communications Security, where 5 BSIMM controls have no direct ISO 13485 equivalent.

How many controls map between BSIMM and ISO 13485?

Of 31 total BSIMM controls, 8 map directly to ISO 13485 controls — representing 26% coverage. The remaining 23 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

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

23 BSIMM controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in BSIMM: Communications Security 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 BSIMM and ISO 13485?

The domain with the highest gap count is BSIMM: Communications Security (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.