FDA QMSR (21 CFR 820) · Pre-audit

Find every FDA QMSR gap before your inspector does.

What Gordios checks in your quality management system, and why it matters.

Regulatory context

The QMSR in practice: ISO 13485, the FDA way.

Since February 2026 the FDA's quality system regulation incorporates ISO 13485 by reference and layers FDA-specific requirements on top. Your QMS has to satisfy both — and prove it.

ISO 13485, incorporated by reference

The QMSR builds on ISO 13485:2016. If your quality system already meets the standard, you're most of the way there — but the FDA-specific additions are exactly where gaps hide.

The FDA-specific layer

Device labelling (21 CFR 801), UDI (21 CFR 830) and FDA record expectations sit on top of ISO 13485. A system built only to the standard can miss them entirely.

Records prove the system runs

An investigator follows records, not intentions. Procedures must be backed by the complaint files, CAPA records and design history that show they were actually applied.

From QSR to QMSR

Documentation written for the old 21 CFR 820 QSR doesn't automatically satisfy the QMSR. The transition is exactly where inconsistencies between old procedures and new requirements surface.

Audit scope

What Gordios examines, point by point.

Every check is located in your documents. Every gap is explained — not a global score, but a traceable, actionable result.

Domain checked	What Gordios verifies	Coverage
QMS & ISO 13485 baseline	Quality system conformity to ISO 13485:2016 as incorporated by the QMSR	Audited
Management responsibility	Quality policy and objectives, responsibilities, and management review inputs and outputs	Audited
Design controls	Design inputs and outputs, verification and validation, and the design history file (21 CFR 820.30)	Audited
CAPA & complaints	Complaint handling and CAPA with effectiveness checks (21 CFR 820.198 and related)	Audited
Labelling & UDI	Device labelling (21 CFR 801) and UDI assignment (21 CFR 830) present and traceable	Audited
Records & DMR/DHF	Device master record and device history records present, controlled and consistent	Audited

Traceability

From requirement to record — without a broken link.

The QMSR expects evidence for every requirement. Gordios checks that each procedure is backed by the records that prove it was followed.

QMSR requirement

Procedure

Record / proof

500+

FDA QMSR analysis points

80%

of audit-prep time saved

Minutes

to your first report

They trust us

**Dr Céline Besnier**CEO, SportSantéClic

How it works

How Gordios audits your QMS.

Three steps, on your real documents. No configuration, no prior training needed.

You import your documents

Quality Manual, procedures, records, design history file, complaint and CAPA files, and labelling documentation — you upload what you have. Gordios adapts to your documentation structure.

Gordios audits against the QMSR

The tool verifies your system against the QMSR — the ISO 13485 baseline and the FDA-specific requirements: presence, consistency, traceability. Automatically.

You receive a traceable report

Every result is located in your documents. Every gap is explained. You know what holds up and what needs attention — with the exact source to back it up.

Field observations

The most frequent gaps Gordios detects.

Not poorly-made systems — but systems documented without the investigator's perspective.

Common gap · 01

QSR documentation not updated to QMSR

Procedures still reference the old 21 CFR 820 QSR structure and haven't been aligned to the ISO 13485 baseline the QMSR now requires.

Common gap · 02

Design validation without the record

Design controls describe validation, but the record proving it was completed and reviewed can't be produced.

Common gap · 03

UDI or labelling gaps

The FDA-specific labelling and UDI requirements are missing — a system built only to ISO 13485 didn't account for them.

Common gap · 04

CAPA closed without effectiveness check

Corrective actions are recorded and closed, but nothing proves they actually worked. The effectiveness verification is missing.

Common gap · 05

Complaint handling not traceable

Complaints are logged, but the link from complaint to investigation to CAPA — and to any reportable event — is broken.

Common gap · 06

The DMR and DHF disagree

The device master record and the device history records describe different configurations. Each was right once; the device moved on.

FAQ

FDA QMSR audit — common questions.

It checks your quality management system against the FDA Quality Management System Regulation (21 CFR Part 820), which incorporates ISO 13485 by reference — plus FDA-specific requirements such as device labelling and UDI.

Since 2 February 2026 the QMSR incorporates ISO 13485:2016 by reference and adds FDA-specific requirements. Gordios checks both the ISO 13485 baseline and the FDA-specific additions.

Gordios performs an automated gap analysis to help you prepare. It is not a regulator; it shows you what an FDA investigator is likely to flag before the real inspection.

Most runs complete in minutes. You upload your documents and Gordios returns a located, traceable report — no configuration or prior setup required.

Your Quality Manual, procedures and records, design history file, device master record, complaint and CAPA files, and labelling documentation. Gordios adapts to your documentation structure.

Yes. Your documents are processed securely and are never used to train models or shared with third parties.

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