Cross-Framework Mapping

FDA Quality Management System Regulation (QMSR)vsDO-178C / ED-12C — Software Considerations in Airborne Systems

See exactly how FDA Quality Management System Regulation (QMSR) controls map to DO-178C / ED-12C — Software Considerations in Airborne Systems. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
23
Gaps Found
15%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA Quality Management System Regulation (QMSR) maps to DO-178C / ED-12C — Software Considerations in Airborne Systems with 15% coverage across 5 directly mapped controls. Analysis of 34 FDA Quality Management System Regulation (QMSR) controls identifies 29 compliance gaps — primarily concentrated in Design and Development.

Source: TheArtOfService Knowledge Graph | 34 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Quality Management System Requirements(1 mappings)

ISO 13485 Cl. 4.1General QMS Requirements
Table A-8, Obj. 3Problem Reporting

Management Responsibility(3 mappings)

ISO 13485 Cl. 5.5Responsibility and Authority3 targets
Table A-1, Obj. 1Software Development Plan
Table A-1, Obj. 2Software Verification Plan
Table A-2, Obj. 2Derived Requirements

Resource Management(3 mappings)

ISO 13485 Cl. 6.4Work Environment and Contamination Control3 targets
Table A-3, Obj. 4HLR Traceability
Table A-5, Obj. 3Source Code Traceability
Table A-8, Obj. 2Baselines and Traceability

Production and Process Controls(3 mappings)

ISO 13485 Cl. 7.5.2Cleanliness and Contamination Control3 targets
Table A-3, Obj. 4HLR Traceability
Table A-5, Obj. 3Source Code Traceability
Table A-8, Obj. 2Baselines and Traceability

Measurement, Analysis, and Improvement(1 mappings)

ISO 13485 Cl. 8.5.2Corrective Action (CAPA)
Table A-8, Obj. 3Problem Reporting

Related Comparisons

Other FDA Quality Management System Regulation (QMSR) comparisons

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

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What are the key differences between FDA Quality Management System Regulation (QMSR) and DO-178C / ED-12C — Software Considerations in Airborne Systems?

FDA Quality Management System Regulation (QMSR) has 34 controls across its framework, while DO-178C / ED-12C — Software Considerations in Airborne Systems covers 36 controls. Direct mapping analysis identifies 5 overlapping controls (15% coverage). The frameworks diverge most significantly in Design and Development, where 8 FDA Quality Management System Regulation (QMSR) controls have no direct DO-178C / ED-12C — Software Considerations in Airborne Systems equivalent.

How many controls map between FDA Quality Management System Regulation (QMSR) and DO-178C / ED-12C — Software Considerations in Airborne Systems?

Of 34 total FDA Quality Management System Regulation (QMSR) controls, 5 map directly to DO-178C / ED-12C — Software Considerations in Airborne Systems controls — representing 15% coverage. The remaining 29 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping FDA Quality Management System Regulation (QMSR) to DO-178C / ED-12C — Software Considerations in Airborne Systems?

29 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in DO-178C / ED-12C — Software Considerations in Airborne Systems. The highest concentration of gaps is in Design and Development with 8 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 FDA Quality Management System Regulation (QMSR) and DO-178C / ED-12C — Software Considerations in Airborne Systems?

The domain with the highest gap count is Design and Development (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.