FDA QMSR Mock Inspections for Medical Device Manufacturers
The FDA's inspection framework for medical devices changed fundamentally on 2 February 2026. QSIT has been retired and replaced by a new risk-based model under the Quality Management System Regulation (QMSR) and Compliance Program Manual CP 7382.850. FDA investigators no longer follow a fixed subsystem checklist — they follow the risk story in your quality system.
What has changed: QSIT to QMSR
The FDA retired QSIT alongside the Quality System Regulation (QSR) on 2 February 2026. In its place, Compliance Program Manual CP 7382.850 introduces a risk-based inspection model organised around six Quality Management System areas — with patient and user safety explicitly at the centre of every investigator decision.
Where QSIT gave manufacturers a predictable, checklist-driven sequence, the new QMSR inspection model is dynamic. FDA investigators now use your own risk management documentation to determine which areas to examine, which records to sample, and how deep to go. The inspection follows the risk, not the subsystem.
For medical device manufacturers, this means the predictability that QSIT provided is gone. Every area of the QMS under 21 CFR Part 820 must be ready — not just the areas historically scrutinised under QSIT.
Why QMSR mock inspections matter
Without a QMSR-aligned mock inspection, medical device manufacturers face significant risk, including:
- 483 observations and warning letters from FDA investigators who find disconnects QSIT rehearsals never tested
- Management oversight findings, now a priority area under CP 7382.850, that were rarely examined under QSIT
- Risk management gaps that signal to investigators where to look harder across all six QMS areas
- CAPA and complaint handling failures exposed by the connected, risk-following inspection approach
- Unprepared subject matter experts who struggle under investigator questioning without rehearsal
- Delayed commercialisation and increased remediation cost after a live inspection finding
A full QMSR system mock inspection
Our mock inspections support medical device manufacturers at every stage, from pre-submission through commercial operations.
Full QMSR system mock inspection
A comprehensive simulation of an FDA inspection under CP 7382.850, covering all six QMS areas and Other Applicable FDA Requirements. Conducted by ex-FDA and senior regulatory auditors, this inspection mirrors the risk-based, patient-centred model that FDA investigators now apply.
- Full QMS review across all six QMSR areas
- Risk management documentation assessment (ISO 14971)
- Management oversight and management review records
- CAPA, complaint handling, and MDR compliance
- Design controls, change control, and production processes
- Front room and back room operational readiness
Trusted by top-tier teams worldwide
How our FDA QMSR mock inspection process works
Step 1: Scoping and needs assessment
We define the inspection scope based on your product portfolio, regulatory status, previous inspection history, and known risk areas. We identify which of the six QMSR areas to weight most heavily and agree the inspection format — full system, targeted, or combined with interview coaching.
Step 2: Auditor assignment
A lead auditor is assigned with direct experience of FDA medical device inspections under 21 CFR Part 820, QMSR, and CP 7382.850. For ex-FDA led inspections, we assign auditors with direct regulatory agency experience.
Step 3 — Inspection preparation
An inspection plan is developed, including the areas and records to be examined. Unlike a standard audit, we do not share the agenda in full — to replicate the unpredictability of a real FDA inspection under the new risk-based model.
Step 4 — Mock inspection execution
The inspection is conducted onsite or remotely. Our auditor takes the role of the FDA investigator, requesting documents, interviewing subject matter experts, and following risk signals across your QMS — exactly as CP 7382.850 instructs real investigators to do.
Step 5 — Inspection report
An inspection-ready report provides a clear narrative of what was found, a structured findings and observations section referencing the applicable QMSR and 21 CFR Part 820 requirements, and a prioritised list of remediation actions. Reports can be delivered using your templates or Apotech's standard format.
Step 6 — Follow-up and CAPA support
Following report delivery, our team remains available to support CAPA development and review, clarification of findings, and effectiveness verification — so the gaps identified in the mock inspection are genuinely closed before the real FDA visit.
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