Framework overlap

Does Belgium CyberFundamentals cover FDA Quality Management System Regulation (QMSR)?

You hold Belgium CyberFundamentals and have been told to do FDA Quality Management System Regulation (QMSR). Here is how much overlaps, control by control.

23% of FDA Quality Management System Regulation (QMSR) you already have

Belgium CyberFundamentals already covers about 23% of FDA Quality Management System Regulation (QMSR), leaving 10 of 13 controls as genuinely new work.

Already covered 0 Likely covered 3 New work 10

No control in Belgium CyberFundamentals maps directly to one in FDA Quality Management System Regulation (QMSR). Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

Nothing in Belgium CyberFundamentals reaches these. This is the list to scope.

QMSR-820.10
Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
QMSR-820.15
Clarification of concepts (§820.15)
QMSR-820.1_3_7
Scope, definitions and incorporation by reference (§§820.1, 820.3, 820.7)
QMSR-820.35
Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35)
QMSR-Coord-ISO13485-MDR-IVDR-Part11
Coordination with ISO 13485:2016, EU MDR/IVDR, FDA Part 11, Cybersecurity Guidance
QMSR-ISO13485-Sec6
Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
QMSR-ISO13485-Sec7_DesignControls
Product realization - Design and Development controls (ISO 13485:2016 Section 7.3)
QMSR-ISO13485-Sec8
Measurement, analysis and improvement (ISO 13485:2016 Section 8)
QMSR-Status
FDA QMSR - corpus status, enforcement landscape, future evolution
QMSR-Transition
Transition from prior QSR + 2 February 2026 application + FDA inspection approach
Show the 3 you already have
QMSR-820.45
Device labelling and packaging controls (§820.45)
QMSR-ISO13485-Sec5
Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)
QMSR-ISO13485-Sec7_Purchasing
Purchasing controls + supplier management (ISO 13485:2016 Section 7.4)

How this is calculated

Already covered means a mapping runs from a control in Belgium CyberFundamentals to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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