NIST SP 800-145vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how NIST SP 800-145 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:
NIST SP 800-145 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 25% coverage across 2 directly mapped controls. Analysis of 8 NIST SP 800-145 controls identifies 6 compliance gaps — primarily concentrated in Deployment Models.
Source: TheArtOfService Knowledge Graph | 8 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 13 of 13 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Procurement and Service Catalogue Alignment(11 mappings)
Governance, Reporting, Education(2 mappings)
Related Comparisons
Other NIST SP 800-145 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between NIST SP 800-145 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
NIST SP 800-145 has 8 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 2 overlapping controls (25% coverage). The frameworks diverge most significantly in Deployment Models, where 1 NIST SP 800-145 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between NIST SP 800-145 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 8 total NIST SP 800-145 controls, 2 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 25% coverage. The remaining 6 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping NIST SP 800-145 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
6 NIST SP 800-145 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Deployment Models with 1 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 NIST SP 800-145 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Deployment Models (1 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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