ISO/IEC 29134:2023vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO/IEC 29134:2023 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 29134:2023 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 7% coverage across 3 directly mapped controls. Analysis of 43 ISO/IEC 29134:2023 controls identifies 40 compliance gaps — primarily concentrated in Risk Assessment.
Source: TheArtOfService Knowledge Graph | 43 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 18 of 18 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 1-4: Introduction and Context(18 mappings)
Related Comparisons
Other ISO/IEC 29134:2023 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO/IEC 29134:2023 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO/IEC 29134:2023 has 43 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 3 overlapping controls (7% coverage). The frameworks diverge most significantly in Risk Assessment, where 4 ISO/IEC 29134:2023 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO/IEC 29134:2023 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 43 total ISO/IEC 29134:2023 controls, 3 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 7% coverage. The remaining 40 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 29134:2023 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
40 ISO/IEC 29134:2023 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Risk Assessment with 4 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 29134:2023 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Risk Assessment (4 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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