ISO 20000-1vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO 20000-1 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 20000-1 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 16% coverage across 8 directly mapped controls. Analysis of 51 ISO 20000-1 controls identifies 43 compliance gaps — primarily concentrated in ISO 20000-1: Service Operation.
Source: TheArtOfService Knowledge Graph | 51 controls analysed | 768 frameworks | 815K+ cross-framework mappings
Control Mappings
Showing 20 of 22 mapped controls across 6 domains. Sign up to explore all 815K+ mappings across 768 frameworks.
Improvement(2 mappings)
Context(2 mappings)
Planning(6 mappings)
Operation - Design Build Transition(1 mappings)
Performance Evaluation(6 mappings)
ISO 20000-1: Service Transition(3 mappings)
+2 more mappings
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Related Comparisons
Other ISO 20000-1 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO 20000-1 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO 20000-1 has 51 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 8 overlapping controls (16% coverage). The frameworks diverge most significantly in ISO 20000-1: Service Operation, where 5 ISO 20000-1 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO 20000-1 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 51 total ISO 20000-1 controls, 8 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 16% coverage. The remaining 43 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 20000-1 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
43 ISO 20000-1 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in ISO 20000-1: Service Operation 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 20000-1 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is ISO 20000-1: Service Operation (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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