Services / MD QMS Assure
MD QMS Assure · Quality & regulatory
ISO 13485 & FDA QMSR
One well-built quality management system can now serve the EU, the UK and the US. We build it, or align the one you have, from gap analysis through to certification.
Why it matters
Since 2 February 2026 the FDA’s Quality Management System Regulation (QMSR) has incorporated ISO 13485 by reference into 21 CFR Part 820. For a manufacturer already certified to ISO 13485, US readiness is now a question of the QMSR delta, not a second system.
For manufacturers without a certified QMS, the fastest route to market is a system written for your team and your product, not a generic template set that auditors recognise on sight.
Who it’s for
- Early-stage MedTech companies building their first certified QMS
- ISO 13485-certified manufacturers preparing for the US market
- Software and SaMD companies adding a QMS around an existing development process
What’s included
- Clause-by-clause gap analysis against ISO 13485, with the QMSR delta for US-bound manufacturers
- Risk-rated remediation roadmap you can execute in-house or with us
- Full QMS build: quality manual, procedures, records and training, written for your team
- Integration of ISO 14971 risk management and, for software, IEC 62304 lifecycle controls
- Support through Stage 1 and Stage 2 certification audits
Deliverable
Gap report and roadmap, then a certification-ready QMS.
Everything we write is yours to own and maintain. We stay available for auditor or reviewer questions on anything we produced.
How it works
Discover
A free 30-minute call to understand your product, markets and deadline.
Define scope
A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.
Build evidence
We do the work with your team, not around it. Everything is written for you to own.
Support delivery
We stay with you through audits, submissions and reviewer questions on anything we wrote.
Questions we’re often asked
Do we need a separate QMS for the FDA?
Usually not. The QMSR incorporates ISO 13485, so the work is identifying and closing the FDA-specific requirements that sit on top of it. The gap analysis shows exactly what those are for your product.
Can you combine ISO 13485 with ISO 27001?
Yes. For software and connected-device companies we build one integrated management system with shared controls and documentation, so you prepare for two certifications without duplicating effort.
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View service →Talk to us about ISO 13485 & QMSR
Book a free 30-minute discovery call. We’ll understand your product and deadline, and tell you exactly what an engagement would involve and cost. No obligation.