NIST SP 800-146vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how NIST SP 800-146 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 800-146 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 25% coverage across 2 directly mapped controls. Analysis of 8 NIST SP 800-146 controls identifies 6 compliance gaps — primarily concentrated in Audit, Cost, and Continuous Improvement.
Source: TheArtOfService Knowledge Graph | 8 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
Cloud Adoption Strategy(6 mappings)
IaaS Operational Posture(5 mappings)
Related Comparisons
Other NIST SP 800-146 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.
Free
- ✓ 718 framework browser
- ✓ Cross-framework mappings (330K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between NIST SP 800-146 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
NIST SP 800-146 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 Audit, Cost, and Continuous Improvement, where 1 NIST SP 800-146 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between NIST SP 800-146 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 8 total NIST SP 800-146 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 800-146 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
6 NIST SP 800-146 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Audit, Cost, and Continuous Improvement 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 800-146 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Audit, Cost, and Continuous Improvement (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.