FDA QMSR Readiness
The Quality Management System Regulation has applied since 2 February 2026. It incorporates ISO 13485:2016 by reference, keeps FDA-specific requirements, and changes what investigators can see. We help you close the gaps and show objective evidence.
Four changes that matter in an inspection
ISO 13485 by reference
Part 820 now incorporates ISO 13485:2016, so ISO clause structure and terminology replace most of the former QSR language.
Additional requirements remain
FDA keeps requirements for areas such as complaint and servicing records, UDI, and labelling and packaging controls, with links to MDR reporting and corrections and removals.
More records open to inspection
Management review, quality audit and supplier audit reports, previously exempt from FDA inspection, can now be reviewed.
Updated inspection approach
FDA has updated its inspection approach for the QMSR, moving away from the QSIT model used under the QSR.
From gap assessment to inspection readiness
- 01QSR-to-QMSR gap assessmentProcedures, records and one representative design file assessed clause by clause.
- 02Requirements mappingISO 13485 clauses and FDA-specific requirements mapped to your processes and owners.
- 03Legacy record reconciliationDHF, DMR and DHR content reconciled with the medical device file, design and development file and production records.
- 04Process remediationSupplier, complaint, design and risk management processes updated and evidenced.
- 05Mock inspectionObjective evidence prepared and tested in a QMSR-style mock inspection.
Renaming legacy DHF, DMR and DHR records does not on its own establish QMSR compliance. The content must meet the relevant ISO 13485 clauses and FDA-specific requirements.
Illustrative QMSR gap report extract · not from a client file
| Reference | Finding | Priority | Action |
|---|---|---|---|
| 21 CFR 820.35 | Complaint records do not capture the MDR reportability determination and rationale | Critical | Revise complaint form and procedure |
| ISO 13485 §5.6 | Management review minutes not structured for external review now that they are inspectable | Major | New template, retrain owners |
| ISO 13485 §7.3.10 | Legacy DHF index omits design transfer and change records | Major | Reconcile into the design and development file |
| 21 CFR 820.45 | Labelling inspection before release not recorded on one line | Major | Add inspection record and check |
| ISO 13485 §7.4.1 | Supplier evaluation criteria not proportionate to risk | Minor | Risk-based supplier criteria |
Choose a starting point
QMSR Readiness Assessment
- Scope
- Procedures, records and one design file
- Outputs
- Gap report, prioritised plan, readiness summary
- Method
- Document review, interviews, record sampling
ISO 13485 Implementation
- Scope
- Process architecture, procedures, records, training
- Outputs
- Certification-ready QMS, first internal audit and management review
- Method
- Phased build, pilot, internal audit, certification support
Audit Readiness Programme
- Scope
- Mock audit, CAPA, staff preparation
- Outputs
- Mock audit report, CAPA plan, front- and back-room plan
- Method
- Audit simulation using the auditor's methodology
Outsourced QMS Support
- Scope
- CAPA, change control, complaints, document control, management review
- Outputs
- Maintained QMS with monthly KPI reporting
- Method
- Dedicated or shared specialists under agreed service levels
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.