C2M2vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how C2M2 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:
C2M2 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 11% coverage across 5 directly mapped controls. Analysis of 47 C2M2 controls identifies 42 compliance gaps — primarily concentrated in C2M2: Incident Response & Recovery.
Source: TheArtOfService Knowledge Graph | 47 controls analysed | 768 frameworks | 815K+ cross-framework mappings
Control Mappings
Showing 17 of 17 mapped controls across 3 domains. Sign up to explore all 815K+ mappings across 768 frameworks.
C2M2: Systems Security(2 mappings)
C2M2: Supply Chain & Configuration(9 mappings)
Risk Management(6 mappings)
Related Comparisons
Other C2M2 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 768 frameworks — at a fraction of consulting costs.
Free
- ✓ 768 framework browser
- ✓ Cross-framework mappings (815K+)
- ✓ 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 C2M2 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
C2M2 has 47 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 5 overlapping controls (11% coverage). The frameworks diverge most significantly in C2M2: Incident Response & Recovery, where 5 C2M2 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between C2M2 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 47 total C2M2 controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 11% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping C2M2 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
42 C2M2 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in C2M2: Incident Response & Recovery with 5 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 C2M2 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is C2M2: Incident Response & Recovery (5 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.