MDS2 (Medical Device)vsISO 13485
See exactly how MDS2 (Medical Device) controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
MDS2 (Medical Device) maps to ISO 13485 with 42% coverage across 10 directly mapped controls. Analysis of 24 MDS2 (Medical Device) controls identifies 14 compliance gaps — primarily concentrated in MDS2 (Medical Device): Organizational Requirements.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 20 of 26 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
MDS2 (Medical Device): Patient Data Protection(14 mappings)
MDS2 (Medical Device): Administrative Safeguards(6 mappings)
+6 more mappings
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Related Comparisons
Other MDS2 (Medical Device) comparisons
Other ISO 13485 comparisons
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What are the key differences between MDS2 (Medical Device) and ISO 13485?
MDS2 (Medical Device) has 24 controls across its framework, while ISO 13485 covers 24 controls. Direct mapping analysis identifies 10 overlapping controls (42% coverage). The frameworks diverge most significantly in MDS2 (Medical Device): Organizational Requirements, where 4 MDS2 (Medical Device) controls have no direct ISO 13485 equivalent.
How many controls map between MDS2 (Medical Device) and ISO 13485?
Of 24 total MDS2 (Medical Device) controls, 10 map directly to ISO 13485 controls — representing 42% coverage. The remaining 14 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping MDS2 (Medical Device) to ISO 13485?
14 MDS2 (Medical Device) controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in MDS2 (Medical Device): 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 MDS2 (Medical Device) and ISO 13485?
The domain with the highest gap count is MDS2 (Medical Device): 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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