ISO 13485vsFIDO2 / WebAuthn
See exactly how ISO 13485 controls map to FIDO2 / WebAuthn. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to FIDO2 / WebAuthn with 9% coverage across 4 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 40 compliance gaps — primarily concentrated in Product Realisation.
Source: TheArtOfService Knowledge Graph | 44 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 3 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
Resource Management(2 mappings)
ISO 13485: Patient Data Protection(1 mappings)
ISO 13485: Technical Safeguards(2 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other FIDO2 / WebAuthn comparisons
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What are the key differences between ISO 13485 and FIDO2 / WebAuthn?
ISO 13485 has 44 controls across its framework, while FIDO2 / WebAuthn covers 16 controls. Direct mapping analysis identifies 4 overlapping controls (9% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct FIDO2 / WebAuthn equivalent.
How many controls map between ISO 13485 and FIDO2 / WebAuthn?
Of 44 total ISO 13485 controls, 4 map directly to FIDO2 / WebAuthn controls — representing 9% coverage. The remaining 40 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to FIDO2 / WebAuthn?
40 ISO 13485 controls have no direct equivalent in FIDO2 / WebAuthn. The highest concentration of gaps is in Product Realisation 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 13485 and FIDO2 / WebAuthn?
The domain with the highest gap count is Product Realisation (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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