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 62% coverage across 5 directly mapped controls. Analysis of 8 MDS2 (Medical Device) controls identifies 3 compliance gaps — primarily concentrated in Malware Detection System Hardening and Cybersecurity Upgrades - MDS2.
Source: TheArtOfService Knowledge Graph | 8 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.
Audit Logging Integrity and Cybersecurity Risk - MDS2(5 mappings)
PHI Data Handling Storage and Transmission - MDS2(8 mappings)
Authentication and Authorization - MDS2(5 mappings)
Physical Security Workstation Disposal and Backup - MDS2(2 mappings)
+2 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 8 controls across its framework, while ISO 13485 covers 29 controls. Direct mapping analysis identifies 5 overlapping controls (62% coverage). The frameworks diverge most significantly in Malware Detection System Hardening and Cybersecurity Upgrades - MDS2, where 1 MDS2 (Medical Device) controls have no direct ISO 13485 equivalent.
How many controls map between MDS2 (Medical Device) and ISO 13485?
Of 8 total MDS2 (Medical Device) controls, 5 map directly to ISO 13485 controls — representing 62% coverage. The remaining 3 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?
3 MDS2 (Medical Device) controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in Malware Detection System Hardening and Cybersecurity Upgrades - MDS2 with 1 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 Malware Detection System Hardening and Cybersecurity Upgrades - MDS2 (1 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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