QMSR Tool

QMSR Gap-Assessment Tool

QSR → QMSR & ISO 13485 – fast, clear, traceable

From February 2, 2026, the QMSR will be in force in the United States. Our online tool shows you clearly and systematically what is changing and includes a complete cross-reference mapping across all requirements.

What the tool delivers

  • Clarity: Complete mapping between QSR ↔ QMSR ↔ ISO 13485
  • Quick orientation: Labels indicating what is replaced and which items are additional requirements
    • Replaced by QMSR, Additional QMSR
    • Replaced by ISO, Additional ISO
  • Helpful explanations: For each requirement, we highlight Similarities, Differences, and Key Requirements
  • Traceable: Cross-linked IDs between all linked requirements
  • Management-ready: Structured results for reviews and decision-making

How it works

In the following image descriptions, you will see at a glance where to find things and what you can do.

All requirements are cross-referenced via IDs (QSR-XXX, ISO-XXX, QMSR-XXX), so you can instantly see where the regulations and the ISO standard have similar requirements.

When you open a requirement, you will get additional, valuable information to support your gap assessment, especially detailed notes on similarities, differences, and key requirements.

The video below explains how the tool works, step by step.

Tool explained

How to get access

  1. Start the trial – Register to test the limited view of the tool (10 rows available).
  2. Unlock the full version – In the dashboard, click “Buy Now” (green button) at the top right.
  3. Close the gaps – Prioritize actions, implement, and document.

What is included

  • Full side-by-side comparison QSR ↔ QMSR ↔ ISO 13485
  • Link your own processes: Use “Add Process” to connect your internal processes
  • Filters: Filter by subparts, sections/paragraphs, gaps, or your processes
  • Short comments: Note similarities, differences, and key points per requirement; annotate your gaps
  • IDs: Direct cross-links between requirements

Price & Offer

Intro price: CHF 399 (instead of CHF 499, valid until September 30, 2025)

FAQ

We’re already ISO 13485 compliant — do we still need this tool?
Yes. QMSR incorporates ISO 13485:2016 by reference, but includes U.S.-specific requirements as well as terminology/process changes. The tool shows exactly where action is needed.

Why not just build our own Excel list?
You get a ready-made, curated mapping with labels, short comments, and cross-links — usable immediately, without weeks of internal effort.

What does the trial include?
The trial displays 10 rows as examples. The full version contains 134 rows.

Is there support/onboarding?
Yes. 15-min demo: Book a call
Email support: info@regulatoryglobe.com

How to buy the full version?

How to buy the full version?
Create a free account – after you have logged in, you will see the green buy button on the top right

Which payment methods are available?
Credit card

Next Step

Shorten your path to QMSR conformity.

 

(Contact: info@regulatoryglobe.com • We typically reply within 1 business day (excluding weekends and public holidays))