FDA Quality Management System Regulation (QMSR)vsEU Medical Devices Regulation (MDR 2017/745)
See exactly how FDA Quality Management System Regulation (QMSR) controls map to EU Medical Devices Regulation (MDR 2017/745). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA Quality Management System Regulation (QMSR) maps to EU Medical Devices Regulation (MDR 2017/745) with 23% coverage across 3 directly mapped controls. Analysis of 13 FDA Quality Management System Regulation (QMSR) controls identifies 10 compliance gaps — primarily concentrated in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 700 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 700 frameworks.
QMSR: Coordination with ISO 13485:2016, EU MDR/IVDR, FDA Part 11(1 mappings)
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)(2 mappings)
Related Comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
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What are the key differences between FDA Quality Management System Regulation (QMSR) and EU Medical Devices Regulation (MDR 2017/745)?
FDA Quality Management System Regulation (QMSR) has 13 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 26 controls. Direct mapping analysis identifies 3 overlapping controls (23% coverage). The frameworks diverge most significantly in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8), where 4 FDA Quality Management System Regulation (QMSR) controls have no direct EU Medical Devices Regulation (MDR 2017/745) equivalent.
How many controls map between FDA Quality Management System Regulation (QMSR) and EU Medical Devices Regulation (MDR 2017/745)?
Of 13 total FDA Quality Management System Regulation (QMSR) controls, 3 map directly to EU Medical Devices Regulation (MDR 2017/745) controls — representing 23% coverage. The remaining 10 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 EU Medical Devices Regulation (MDR 2017/745)?
10 FDA Quality Management System Regulation (QMSR) controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). The highest concentration of gaps is in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) with 4 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 EU Medical Devices Regulation (MDR 2017/745)?
The domain with the highest gap count is QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8) (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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