IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsISO 20000-1
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ISO 20000-1. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
IEC 62304:2015 Medical Device Software Lifecycle Processes maps to ISO 20000-1 with 24% coverage across 12 directly mapped controls. Analysis of 34 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 39 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 34 controls analysed | 715 frameworks | 415K+ cross-framework mappings
Control Mappings
Showing 20 of 22 mapped controls across 9 domains. Sign up to explore all 415K+ mappings across 715 frameworks.
Clause 4 - General Requirements(2 mappings)
Clause 5 - Software Development Process(8 mappings)
Requirements(2 mappings)
Design(2 mappings)
Risk Management(2 mappings)
Clause 7 - Software Risk Management Process(2 mappings)
Configuration(1 mappings)
Clause 8 - Software Configuration Management Process(1 mappings)
+2 more mappings
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Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other ISO 20000-1 comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 20000-1?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 34 controls across its framework, while ISO 20000-1 covers 52 controls. Direct mapping analysis identifies 12 overlapping controls (24% coverage). The frameworks diverge most significantly in Clause 9 - Software Problem Resolution Process, where 6 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct ISO 20000-1 equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 20000-1?
Of 34 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 12 map directly to ISO 20000-1 controls — representing 24% coverage. The remaining 39 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping IEC 62304:2015 Medical Device Software Lifecycle Processes to ISO 20000-1?
39 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ISO 20000-1. The highest concentration of gaps is in Clause 9 - Software Problem Resolution Process with 6 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 IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 20000-1?
The domain with the highest gap count is Clause 9 - Software Problem Resolution Process (6 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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