IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsDO-178C / ED-12C — Software Considerations in Airborne Systems
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to DO-178C / ED-12C — Software Considerations in Airborne Systems. 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 DO-178C / ED-12C — Software Considerations in Airborne Systems with 27% coverage across 8 directly mapped controls. Analysis of 30 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 22 compliance gaps — primarily concentrated in Clause 9 — Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 30 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 20 of 20 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Clause 4 — General Requirements(2 mappings)
Clause 5 — Software Development Process(10 mappings)
Clause 7 — Software Risk Management Process(3 mappings)
Clause 8 — Software Configuration Management Process(2 mappings)
Clause 9 — Software Problem Resolution Process(3 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other DO-178C / ED-12C — Software Considerations in Airborne Systems comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 693 frameworks — at a fraction of consulting costs.
Free
- ✓ 693 framework browser
- ✓ Cross-framework mappings (819K+)
- ✓ 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 IEC 62304:2015 Medical Device Software Lifecycle Processes and DO-178C / ED-12C — Software Considerations in Airborne Systems?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls across its framework, while DO-178C / ED-12C — Software Considerations in Airborne Systems covers 36 controls. Direct mapping analysis identifies 8 overlapping controls (27% coverage). The frameworks diverge most significantly in Clause 9 — Software Problem Resolution Process, where 6 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct DO-178C / ED-12C — Software Considerations in Airborne Systems equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and DO-178C / ED-12C — Software Considerations in Airborne Systems?
Of 30 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to DO-178C / ED-12C — Software Considerations in Airborne Systems controls — representing 27% coverage. The remaining 22 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 DO-178C / ED-12C — Software Considerations in Airborne Systems?
22 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in DO-178C / ED-12C — Software Considerations in Airborne Systems. The highest concentration of gaps is in Clause 9 — Software Problem Resolution Process with 6 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 DO-178C / ED-12C — Software Considerations in Airborne Systems?
The domain with the highest gap count is Clause 9 — Software Problem Resolution Process (6 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.