EU Medical Devices Regulation (MDR 2017/745)vsFDA Quality Management System Regulation (QMSR)
See exactly how EU Medical Devices Regulation (MDR 2017/745) controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
According to the TheArtOfService Compliance Knowledge Graph:
EU Medical Devices Regulation (MDR 2017/745) maps to FDA Quality Management System Regulation (QMSR) with 12% coverage across 3 directly mapped controls. Analysis of 26 EU Medical Devices Regulation (MDR 2017/745) controls identifies 23 compliance gaps, primarily concentrated in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X).
Source: TheArtOfService Knowledge Graph | 26 controls analysed | 686 frameworks | 306K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 3 domains. Sign up to explore all 306K+ mappings across 686 frameworks.
MDR - Making Available + Economic Operators (Ch II)(1 mappings)
MDR - Clinical Evaluation + Clinical Investigations (Ch VI)(1 mappings)
MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)(1 mappings)
A EU Medical Devices Regulation (MDR 2017/745) to FDA Quality Management System Regulation (QMSR) crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which FDA Quality Management System Regulation (QMSR) controls your existing EU Medical Devices Regulation (MDR 2017/745) work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 12% in the header counts how many EU Medical Devices Regulation (MDR 2017/745) controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many FDA Quality Management System Regulation (QMSR) controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
Related Comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between EU Medical Devices Regulation (MDR 2017/745) and FDA Quality Management System Regulation (QMSR)?
EU Medical Devices Regulation (MDR 2017/745) has 26 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 3 overlapping controls (12% coverage). The frameworks diverge most significantly in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X), where 7 EU Medical Devices Regulation (MDR 2017/745) controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between EU Medical Devices Regulation (MDR 2017/745) and FDA Quality Management System Regulation (QMSR)?
Of 26 total EU Medical Devices Regulation (MDR 2017/745) controls, 3 map directly to FDA Quality Management System Regulation (QMSR) controls, representing 12% coverage. The remaining 23 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping EU Medical Devices Regulation (MDR 2017/745) to FDA Quality Management System Regulation (QMSR)?
23 EU Medical Devices Regulation (MDR 2017/745) controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) with 7 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 EU Medical Devices Regulation (MDR 2017/745) and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (7 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.