IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsNIST Privacy Framework
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to NIST Privacy Framework. 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 NIST Privacy Framework with 15% coverage across 7 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 43 compliance gaps — primarily concentrated in Clause 5 - Software Development Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 15 of 15 mapped controls across 7 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
Clause 4 - General Requirements(3 mappings)
Clause 5 - Software Development Process(3 mappings)
Risk Management(3 mappings)
Clause 7 - Software Risk Management Process(3 mappings)
Configuration(1 mappings)
Clause 8 - Software Configuration Management Process(1 mappings)
Clause 9 - Software Problem Resolution Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other NIST Privacy Framework comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST Privacy Framework?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while NIST Privacy Framework covers 8 controls. Direct mapping analysis identifies 7 overlapping controls (15% coverage). The frameworks diverge most significantly in Clause 5 - Software Development Process, where 7 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct NIST Privacy Framework equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST Privacy Framework?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 7 map directly to NIST Privacy Framework controls — representing 15% 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 IEC 62304:2015 Medical Device Software Lifecycle Processes to NIST Privacy Framework?
43 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in NIST Privacy Framework. The highest concentration of gaps is in Clause 5 - Software Development Process with 7 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 NIST Privacy Framework?
The domain with the highest gap count is Clause 5 - Software Development Process (7 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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