Preserve the evidence chain: how to specify a medical device QMS
A medical device QMS must do more than manage documents, CAPAs, complaints, and training. It must provide a controlled, connected record of how the organization designs, manufactures, supplies, services, monitors, and improves devices across their lifecycle. Preserve the evidence chain is a handbook for the decision makers who put together a QMS RFP or URS for a medical device organization.
The regulatory baseline changed on 2 February 2026. FDA's Quality Management System Regulation (QMSR) amended 21 CFR Part 820 and incorporated ISO 13485:2016 by reference, and FDA withdrew the Quality System Inspection Technique (QSIT) and began inspecting under its updated compliance program. ISO 13485 certification alone does not guarantee FDA compliance: QMSR keeps additional FDA-specific requirements, so a QMS must support both. Read more on GxP compliance.
What should a medical device QMS RFP or URS include?
A medical device QMS RFP or URS should include requirements for document control and training management, CAPA, nonconformance, and risk management, complaint, service, and post-market management, supplier and manufacturing quality, and design change, audit, and inspection readiness. It should also cover implementation and governance, and tag each requirement with its ISO 13485 clause, FDA QMSR requirement, or EU MDR/IVDR need.
Ask suppliers to demonstrate one connected chain: a complaint trend that becomes a CAPA linked to affected lots, service records, a supplier component, and the risk file, leads to a design change and retraining, and produces an inspection-ready evidence package with every record, approval, signature, version, and audit trail. A connected QMS keeps that chain intact.
Who this handbook is for
Quality leaders, regulatory teams, product-development leaders, manufacturing teams, supplier-quality teams, service organizations, IT teams, and program owners preparing a QMS RFP or URS for a medical device organization.
For a one-page overview of how Uncountable approaches this, read the solution brief Quality management system (QMS) with Uncountable: close the loop from deviation to CAPA.
What's inside
Inside this handbook:
- The new QMSR regulatory baseline, and why ISO 13485 certification alone is not enough
- The medical device QMS as a connected system of records
- Requirements for document control and training management, including site-level effectivity and competency
- Requirements for CAPA, nonconformance, and risk management linked to the risk file
- Requirements for complaint, service, and post-market management, including separate US and EU reportability decisions
- Requirements for supplier and manufacturing quality, including supplier change notifications
- Requirements for design change, audit, and inspection readiness
- A supplier demonstration scenario and common mistakes for each chapter, plus implementation governance and a final evaluation checklist
Download the handbook to specify a QMS that preserves the evidence chain from complaint to closure.
FAQs
Preserve the evidence chain is a handbook on how to write a practical QMS RFP or URS for ISO 13485 and FDA QMSR readiness. It covers document control and training, CAPA, nonconformance and risk management, complaints, service and post-market management, supplier and manufacturing quality, design change, audit and inspection readiness, and implementation and governance.
The handbook is for decision makers who put together a QMS RFP or URS for a medical device organization, including quality leaders, regulatory teams, product-development leaders, manufacturing teams, supplier-quality teams, service organizations, IT teams, and program owners.
No. FDA has stated that it will not require or issue ISO 13485 certificates, and that a certificate does not exempt a manufacturer from FDA inspection. The QMSR incorporates ISO 13485:2016 by reference while retaining additional FDA-specific requirements under the Federal Food, Drug, and Cosmetic Act, so a QMS must support both.
A medical device QMS RFP or URS should include requirements for document control and training, CAPA, nonconformance and risk management, complaint, service and post-market management, supplier and manufacturing quality, design change, and audit and inspection readiness, with each requirement tagged to its ISO 13485 clause, FDA QMSR requirement, EU MDR/IVDR need, or internal procedure.
On 2 February 2026, FDA's Quality Management System Regulation became effective, amending 21 CFR Part 820 and incorporating ISO 13485:2016 and Clause 3 of ISO 9000:2015 by reference. On the same date, FDA withdrew the Quality System Inspection Technique (QSIT) and began inspecting under its updated compliance program for medical device manufacturers.
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