ISO 13485vsMDS2 (Medical Device)
See exactly how ISO 13485 controls map to MDS2 (Medical Device). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to MDS2 (Medical Device) with 45% coverage across 13 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 16 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.
Source: TheArtOfService Knowledge Graph | 29 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 22 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource Management(1 mappings)
ISO 13485: Patient Data Protection(10 mappings)
ISO 13485: Administrative Safeguards(6 mappings)
ISO 13485: Technical Safeguards(2 mappings)
ISO 13485: Physical Safeguards(1 mappings)
+2 more mappings
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Related Comparisons
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What are the key differences between ISO 13485 and MDS2 (Medical Device)?
ISO 13485 has 29 controls across its framework, while MDS2 (Medical Device) covers 8 controls. Direct mapping analysis identifies 13 overlapping controls (45% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct MDS2 (Medical Device) equivalent.
How many controls map between ISO 13485 and MDS2 (Medical Device)?
Of 29 total ISO 13485 controls, 13 map directly to MDS2 (Medical Device) controls — representing 45% coverage. The remaining 16 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 MDS2 (Medical Device)?
16 ISO 13485 controls have no direct equivalent in MDS2 (Medical Device). The highest concentration of gaps is in ISO 13485: 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 ISO 13485 and MDS2 (Medical Device)?
The domain with the highest gap count is ISO 13485: Organizational Requirements (4 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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