QA/RA Consulting, Auditing & Training
(5-Part Microlearning Video Series)
Audience: Medical device professionals, quality managers, and compliance teams
The FDA just swapped out its 25-year-old Quality System Regulation (QSR) for the snazzy, ISO 13485-based Quality Management System Regulation (QMSR). The final rule dropped on January 31, 2024, and the clock is ticking toward full enforcement on February 2, 2026 – that’s a two-year timeframe and not a day more. Miss that deadline and you’ll be explaining yourself to an FDA investigator faster than you can say “Form 483.”
Watch time: 3 min
In this video
Pro tip: Start training ops and suppliers now—nobody ever complained that they were “too ready” for an FDA inspection.
Watch time: 3 min
| What Changed | Why It Matters |
|---|---|
| Structure swapped from subpart-heavy QSR to ISO 13485 clause order | Your QMS manual can finally look the same on both sides of the Atlantic |
| Risk-based thinking baked in | FDA expects risk management throughout the product life cycle, not bolted on at the end |
| Supplemental provisions (complaint handling, traceability, servicing) | These FDA-only add-ons keep “US market” nuances intact |
| Terminology update (e.g., “device master record” ≈ ISO’s “medical device file”) | Less glossary juggling for global teams |
| Documentation flexibility | If ISO 13485 lets you, do it digitally, FDA will too – just keep those records easily retrievable |
5-Step Action Checklist
We invite you and your team to register for one of these courses offered by ELIQUENT Life Sciences for in-depth expansion:
If you find the videos helpful, share this post with a colleague who’s still clinging to the old QSR like it’s vinyl in a Spotify world. Because February 2026 will arrive whether your CAPA log is ready or not.
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