IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsUK GDPR (UK General Data Protection Regulation)
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to UK GDPR (UK General Data Protection Regulation). 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 UK GDPR (UK General Data Protection Regulation) with 9% coverage across 6 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 44 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 5 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
Requirements(1 mappings)
Clause 5 - Software Development Process(2 mappings)
Design(1 mappings)
Risk Management(1 mappings)
Clause 7 - Software Risk Management Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other UK GDPR (UK General Data Protection Regulation) comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and UK GDPR (UK General Data Protection Regulation)?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while UK GDPR (UK General Data Protection Regulation) covers 44 controls. Direct mapping analysis identifies 6 overlapping controls (9% coverage). The frameworks diverge most significantly in Clause 9 - Software Problem Resolution Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct UK GDPR (UK General Data Protection Regulation) equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and UK GDPR (UK General Data Protection Regulation)?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 6 map directly to UK GDPR (UK General Data Protection Regulation) controls — representing 9% coverage. The remaining 44 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 UK GDPR (UK General Data Protection Regulation)?
44 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in UK GDPR (UK General Data Protection Regulation). The highest concentration of gaps is in Clause 9 - Software Problem Resolution 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 UK GDPR (UK General Data Protection Regulation)?
The domain with the highest gap count is Clause 9 - Software Problem Resolution 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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