QMSR Resource Hub

QMSR is coming. Is your quality system ready?

The FDA’s new Quality Management System Regulation takes effect February 2, 2026

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This page is your one-stop resource for understanding what’s changing, what’s at stake, and how to stay compliant.

Get The QMSR Readiness Toolkit

QMSR isn’t a suggestion. It’s a mandate.

QMSR replaces the FDA’s legacy QSR rule and harmonizes it with ISO 13485. By early 2026, every medical device company must align with this new framework - or risk being out of compliance.

This impacts everyone

ISO 13485 certification does not mean you are automatically in compliance with QMSR.

Change is coming

Internal audits, supplier audits, and management reviews must be available for FDA inspection.

Now is the time to act

Devices that are not in compliance with QMSR will be deemed “adulterated” by the FDA.

QMSR has no grace period. Your
quality system must be updated
and aligned by February 2, 2026.

Out with QSR. In with
QMSR. Here’s what’s
different.

Terminology shift: DHF → Design & Development File, DHR → Batch Records
Risk management: Must be formalized and linked across lifecycle
Record access: FDA can now request internal audits, supplier reviews, and management minutes

Hard deadline: February 2, 2026 - no phase-in period

See what's changing

Your complete QMSR readiness toolkit

We’ve gathered expert-led resources, templates, checklists, and events to help you prepare with confidence. Practical, proven tools from medical device experts at Greenlight Guru.

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You don’t need to rebuild your QMS. You need one that’s already ready.

Most systems require months of reconfiguration to meet QMSR requirements. Greenlight Guru’s platform is already built around FDA and ISO standards - with audit-tested workflows, modern risk management, and built-in terminology updates.

Aligned out of
the box

Preloaded with updated fields and templates that reflect QMSR language (Design & Development File, Medical Device File, etc.)

Audit-ready records
by design

Internal audits, supplier reviews, and management minutes captured and linked automatically

Built for medtech -
not adapted for it

Purpose-built workflows mean less time interpreting guidance and more time executing

Ultimate Guide to Comparing Quality Management System Solutions

QMSR Resource Hub

QMSR is coming. Is your quality system ready?