ISO/IEC 29100:2024vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO/IEC 29100:2024 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 29100:2024 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 8% coverage across 3 directly mapped controls. Analysis of 40 ISO/IEC 29100:2024 controls identifies 37 compliance gaps — primarily concentrated in Principles.
Source: TheArtOfService Knowledge Graph | 40 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 18 of 18 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 1-3: Framework Introduction(12 mappings)
Clause 4: Privacy Framework Components(6 mappings)
Related Comparisons
Other ISO/IEC 29100:2024 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO/IEC 29100:2024 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO/IEC 29100:2024 has 40 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 3 overlapping controls (8% coverage). The frameworks diverge most significantly in Principles, where 11 ISO/IEC 29100:2024 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO/IEC 29100:2024 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 40 total ISO/IEC 29100:2024 controls, 3 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 8% coverage. The remaining 37 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 29100:2024 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
37 ISO/IEC 29100:2024 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Principles with 11 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 29100:2024 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Principles (11 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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