QSR-to-QMSR Paper Gap Audit
MDP services for our clients
Is Your Quality Management System Ready for QMSR?
As FDA’s transition from the QSR to the QMSR approaches, many medical device manufacturers are discovering that “substantially equivalent” doesn’t mean “completely aligned.” Even companies with solid QSR documentation are finding hidden gaps when measured against ISO 13485:2016.
Medical Devices and Pharma, offers QMSR Paper Gap Audits – a focused, affordable review of your Quality Manual and top-level SOPs. We map your current documentation to the QMSR, identify missing or outdated content, and highlight the updates you’ll need to meet FDA’s new expectations.
If you’re unsure whether your documentation will pass inspection after February 6, 2026, this audit is a smart first step.
What You Get with MDP’s QMSR Paper Gap Audit:
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Clause-by-Clause Mapping – We compare your Quality Manual and SOPs against ISO 13485:2016 / QMSR requirements
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Clear Gap Identification – We flag missing content, outdated QSR references, and areas needing structural updates
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Risk-Based Prioritization – Each finding is rated by urgency and regulatory risk so you know what to fix first
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Actionable Recommendations – Guidance on how to remediate gaps and prepare for a full QMSR rollout
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No Disruption – This is a paper audit—no site visit or internal disruptions required
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Fast Turnaround – Most reports delivered within 10 business days.
Get Ahead of the Deadline
The QMSR becomes fully enforceable in February 2026—but smart companies are taking action now. Our paper gap audit gives you a head start, reduces compliance risk, and helps you budget and plan your transition with confidence.
Ready to see where you stand?
Contact us today to schedule your QMSR Paper Audit or learn more about how Medical Devices and Pharma can support your full transition strategy.