ISO 27005vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO 27005 controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 27005 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 18% coverage across 5 directly mapped controls. Analysis of 40 ISO 27005 controls identifies 35 compliance gaps — primarily concentrated in Risk Assessment.
Source: TheArtOfService Knowledge Graph | 40 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 15 of 15 mapped controls across 3 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
Risk Treatment(1 mappings)
ISO 27005: Risk Framework & Governance(8 mappings)
ISO 27005: Risk Monitoring & Review(6 mappings)
Related Comparisons
Other ISO 27005 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO 27005 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO 27005 has 40 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 5 overlapping controls (18% coverage). The frameworks diverge most significantly in Risk Assessment, where 8 ISO 27005 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO 27005 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 40 total ISO 27005 controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 18% coverage. The remaining 35 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 27005 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
35 ISO 27005 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Risk Assessment with 8 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 27005 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Risk Assessment (8 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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