Cross-Framework Mapping

DO-178C / ED-12C — Software Considerations in Airborne SystemsvsIEC 62304:2015 Medical Device Software Lifecycle Processes

See exactly how DO-178C / ED-12C — Software Considerations in Airborne Systems controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.

20
Controls Mapped
16
Gaps Found
25%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

DO-178C / ED-12C — Software Considerations in Airborne Systems maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 25% coverage across 9 directly mapped controls. Analysis of 36 DO-178C / ED-12C — Software Considerations in Airborne Systems controls identifies 27 compliance gaps — primarily concentrated in Testing and Integration Verification (Tables A-6 & A-7).

Source: TheArtOfService Knowledge Graph | 36 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.

Software Planning Process(10 mappings)

Table A-1, Obj. 1Software Development Plan3 targets
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design
IEC62304-7.2Risk Control Measures
Table A-1, Obj. 2Software Verification Plan3 targets
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design
IEC62304-7.2Risk Control Measures
Table A-1, Obj. 3Software Configuration Management Plan4 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
IEC62304-8.2Change Control
IEC62304-9.4Use Change Control Process

Software Development Process(3 mappings)

Table A-2, Obj. 2Derived Requirements3 targets
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design
IEC62304-7.2Risk Control Measures

Verification of Requirements (Tables A-3 & A-4)(1 mappings)

Table A-3, Obj. 4HLR Traceability
IEC62304-5.1Software Development Planning

Verification of Design and Code (Tables A-4 & A-5)(1 mappings)

Table A-5, Obj. 3Source Code Traceability
IEC62304-5.1Software Development Planning

Configuration Management (Table A-8)(5 mappings)

Table A-8, Obj. 2Baselines and Traceability
IEC62304-5.1Software Development Planning
Table A-8, Obj. 3Problem Reporting2 targets
IEC62304-4.1Quality Management System
IEC62304-9.6Analyze Problems for Trends
Table A-8, Obj. 4Change Control2 targets
IEC62304-8.2Change Control
IEC62304-9.4Use Change Control Process

Related Comparisons

Other DO-178C / ED-12C — Software Considerations in Airborne Systems comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

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What are the key differences between DO-178C / ED-12C — Software Considerations in Airborne Systems and IEC 62304:2015 Medical Device Software Lifecycle Processes?

DO-178C / ED-12C — Software Considerations in Airborne Systems has 36 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 9 overlapping controls (25% coverage). The frameworks diverge most significantly in Testing and Integration Verification (Tables A-6 & A-7), where 6 DO-178C / ED-12C — Software Considerations in Airborne Systems controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.

How many controls map between DO-178C / ED-12C — Software Considerations in Airborne Systems and IEC 62304:2015 Medical Device Software Lifecycle Processes?

Of 36 total DO-178C / ED-12C — Software Considerations in Airborne Systems controls, 9 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 25% coverage. The remaining 27 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping DO-178C / ED-12C — Software Considerations in Airborne Systems to IEC 62304:2015 Medical Device Software Lifecycle Processes?

27 DO-178C / ED-12C — Software Considerations in Airborne Systems controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Testing and Integration Verification (Tables A-6 & A-7) 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 DO-178C / ED-12C — Software Considerations in Airborne Systems and IEC 62304:2015 Medical Device Software Lifecycle Processes?

The domain with the highest gap count is Testing and Integration Verification (Tables A-6 & A-7) (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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