Quality System Remediation
QMSR Transition
FDA's Quality Management System Regulation took effect February 2, 2026. Many firms are still catching up, and the first inspections under QMSR are where unfinished work shows. We help you close the gap from wherever your system stands today.
What You Receive
- 01QMSR Gap Findings
- 02Transition Plan
- 03Procedure Revision List
- 04Inspectable Records Review
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
QMSR amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, replacing the Quality System Regulation's requirements. It keeps FDA-specific additions, including 820.35 for records such as complaint and servicing records and UDI, and 820.45 for labeling and packaging controls. Inspections now follow Compliance Program 7382.850 instead of QSIT.
The work depends on where you start, so we run it as one of two tracks. If you already hold ISO 13485 certification, the transition is a delta: the FDA-specific additions, the move from QSR terms such as DHF, DMR and DHR to ISO 13485 vocabulary, and the removal of the 820.180(c) exception that kept internal audit, management review and supplier audit records away from investigators. Those records are now open to FDA inspection.
If your system was built only to the old QSR, the transition is larger. ISO 13485 brings structure and expectations that QSR-era procedures often don't address directly, such as a risk-based approach to controlling QMS processes. For those firms we run a full transition: an assessment against QMSR, a sequenced plan, and procedure updates in an order that fits your operations.
When You Need It
- Your procedures still cite QSR sections and use DHF, DMR and DHR as their controlling terms.
- You hold ISO 13485 certification but haven't mapped the FDA-specific QMSR additions.
- Your quality system was built only to the old QSR and has never been assessed against ISO 13485.
- Internal audit and management review records were written on the assumption that FDA would not read them.
- Labeling and packaging controls haven't been reviewed against 820.45.
- You haven't had an FDA inspection under QMSR yet and want to be ready for the first one.
What We Do
- 01
Choose the Track
We confirm your starting point, an ISO 13485 system or a QSR-only system, and scope the work as a delta or a full transition.
- 02
Assess Against QMSR
The AI-assisted first pass maps your documents against QMSR, including ISO 13485:2016 and the FDA-specific additions, and an advisor reviews every result.
- 03
Address the FDA-Specific Requirements
We review your procedures and records against the records requirements in 820.35 and the labeling and packaging controls in 820.45.
- 04
Update Terminology and Cross-References
Procedures, forms and the quality manual are updated to reference QMSR and ISO 13485 correctly, without leaving obsolete QSR structures behind.
- 05
Prepare Newly Inspectable Records
Internal audit, management review and supplier audit records are reviewed for accuracy, objectivity and follow-through now that FDA can inspect them.
- 06
Track Through to Evidence
Every change goes into the action plan with an owner and evidence requirement, and the advisor reviews the evidence before the item closes.
Deliverables
QMSR Gap Findings
Advisor-reviewed findings against QMSR, with sources, severity and gap type.
Transition Plan
A sequenced plan for the delta or full transition, with owners, due dates and evidence requirements.
Procedure Revision List
Every procedure, form and record template affected, with the change each one needs.
Inspectable Records Review
Findings on the internal audit, management review and supplier audit records that are now open to FDA.
How the Platform Helps
Assessment on Your Existing Documents
Upload your current procedures and records, including eQMS exports. No migration is required, and originals are preserved.
Findings Mapped to QMSR
Each finding cites the requirement and the source document and location, so reviewers can check the reasoning.
Action Plan Through Closure
Owners submit evidence, the advisor accepts it or requests a revision, and an immutable history records each step.
Audits and Inspections It Prepares You For
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
FDA Non-Baseline Surveillance Inspection
A focused FDA surveillance inspection that goes deep on selected QMS areas under Compliance Program 7382.850.
FDA Foreign Facility Inspection
FDA inspection of a manufacturer outside the US that makes devices for the US market.
ISO 13485 Recertification Audit
The pre-expiry audit that reviews the whole ISO 13485 system and how it performed over the three-year cycle.
MDSAP Audit
One audit by a recognized auditing organization that covers several participating regulators, including FDA.
Internal Audit
Audits your own team runs of your quality system, now open to FDA inspection under the QMSR.
Standards and Regulations in Scope
Questions About This Service
Is it too late to transition?
QMSR has been in effect since February 2, 2026, so FDA now inspects against it. Firms still catching up should start with the gaps an investigator is most likely to see: risk management, the FDA-specific additions and the records now open to inspection.
We hold ISO 13485 certification. Is there anything left to do?
Usually yes, though the work is smaller. QMSR adds FDA-specific requirements such as 820.35 records and 820.45 labeling and packaging controls, and FDA can now inspect internal audit, management review and supplier audit records. A delta assessment shows what remains.
Do we still need a DHF, DMR and DHR?
QMSR uses ISO 13485 vocabulary rather than the QSR's DHF, DMR and DHR. The underlying records still need to exist under the standard's terms, so the task is mostly mapping and updating references, not discarding records.
How do inspections change under QMSR?
FDA stopped using QSIT on February 2, 2026. Device QMS inspections now follow Compliance Program 7382.850, which is risk-based, starts from your risk management documentation and groups requirements into six QMS areas plus four other FDA requirements.
Do we need ISO 13485 certification to meet QMSR?
QMSR incorporates ISO 13485:2016 by reference, but FDA inspects against the regulation itself rather than relying on a certificate. Whether certification makes sense for you depends on your markets and customers.
Request an Assessment
Discuss QMSR Transition With an Advisor
Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
