ISO 19011vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO 19011 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 19011 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 11% coverage across 2 directly mapped controls. Analysis of 18 ISO 19011 controls identifies 16 compliance gaps — primarily concentrated in ISO 19011: Operational Controls.
Source: TheArtOfService Knowledge Graph | 18 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
ISO 19011: Performance Evaluation(2 mappings)
ISO 19011: Improvement(2 mappings)
Related Comparisons
Other ISO 19011 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO 19011 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO 19011 has 18 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 2 overlapping controls (11% coverage). The frameworks diverge most significantly in ISO 19011: Operational Controls, where 5 ISO 19011 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO 19011 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 18 total ISO 19011 controls, 2 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 11% coverage. The remaining 16 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 19011 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
16 ISO 19011 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in ISO 19011: Operational Controls 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 19011 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is ISO 19011: Operational Controls (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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