IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsVoluntary Principles on Security and Human Rights (VPs)
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to Voluntary Principles on Security and Human Rights (VPs). 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 Voluntary Principles on Security and Human Rights (VPs) with 6% coverage across 2 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 48 compliance gaps — primarily concentrated in Clause 5 - Software Development Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
Clause 4 - General Requirements(1 mappings)
Clause 9 - Software Problem Resolution Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other Voluntary Principles on Security and Human Rights (VPs) comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and Voluntary Principles on Security and Human Rights (VPs)?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while Voluntary Principles on Security and Human Rights (VPs) covers 35 controls. Direct mapping analysis identifies 2 overlapping controls (6% coverage). The frameworks diverge most significantly in Clause 5 - Software Development Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct Voluntary Principles on Security and Human Rights (VPs) equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and Voluntary Principles on Security and Human Rights (VPs)?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 2 map directly to Voluntary Principles on Security and Human Rights (VPs) controls — representing 6% coverage. The remaining 48 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 Voluntary Principles on Security and Human Rights (VPs)?
48 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in Voluntary Principles on Security and Human Rights (VPs). The highest concentration of gaps is in Clause 5 - Software Development Process with 8 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 Voluntary Principles on Security and Human Rights (VPs)?
The domain with the highest gap count is Clause 5 - Software Development Process (8 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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