ISO/IEC 27003:2017vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO/IEC 27003:2017 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 27003:2017 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 11% coverage across 8 directly mapped controls. Analysis of 72 ISO/IEC 27003:2017 controls identifies 64 compliance gaps — primarily concentrated in Support (Clause 7).
Source: TheArtOfService Knowledge Graph | 72 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 25 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Operation (Clause 8)(9 mappings)
Improvement (Clause 10)(6 mappings)
Context of the Organization (Clause 4)(5 mappings)
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Related Comparisons
Other ISO/IEC 27003:2017 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO/IEC 27003:2017 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO/IEC 27003:2017 has 72 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 8 overlapping controls (11% coverage). The frameworks diverge most significantly in Support (Clause 7), where 9 ISO/IEC 27003:2017 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO/IEC 27003:2017 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 72 total ISO/IEC 27003:2017 controls, 8 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 11% coverage. The remaining 64 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 27003:2017 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
64 ISO/IEC 27003:2017 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Support (Clause 7) with 9 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 27003:2017 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Support (Clause 7) (9 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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