QA/RA Consulting, Auditing & Training
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QA/RA Consulting, Auditing & Training
(5-Part Microlearning Video Series)
Audience: Medical device professionals, quality managers, and compliance teams
The FDA has officially moved on from its 25‑year‑old QSR, replacing it with the ISO 13485‑aligned QMSR. That shift isn’t theoretical anymore—it’s enforceable, and inspection expectations have changed accordingly.
| 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.
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