ISO/IEC 27004:2016vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO/IEC 27004:2016 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/IEC 27004:2016 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 10% coverage across 4 directly mapped controls. Analysis of 30 ISO/IEC 27004:2016 controls identifies 41 compliance gaps — primarily concentrated in Annex Examples.
Source: TheArtOfService Knowledge Graph | 30 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 20 of 24 mapped controls across 4 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
Clause 1-4: Introductory Clauses(6 mappings)
Annex Examples(6 mappings)
Annex A: Information Security Measurement Model(6 mappings)
Annex B: Example Measurements(2 mappings)
+4 more mappings
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Related Comparisons
Other ISO/IEC 27004:2016 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO/IEC 27004:2016 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO/IEC 27004:2016 has 30 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 4 overlapping controls (10% coverage). The frameworks diverge most significantly in Annex Examples, where 5 ISO/IEC 27004:2016 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO/IEC 27004:2016 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 30 total ISO/IEC 27004:2016 controls, 4 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 10% coverage. The remaining 41 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 27004:2016 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
41 ISO/IEC 27004:2016 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Annex Examples with 5 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/IEC 27004:2016 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Annex Examples (5 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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