Contact SalesSupport Center
The FDA released Draft Guidance Quality Management System Information for Certain Premarket Submission Reviews in October 2025 to prepare medical device manufacturers for updated QMS requirements after the QMSR update. While being a non-binding document, this draft guidance provides insight into how the FDA will be expected to incorporate QMSR updates in their premarket submission process.
We have prepared this checklist for medical device manufacturers to use to see if their QMS stands up to par with FDA recommendations. Although not legally enforceable, this guidance and checklist can help companies identify areas of success and deficiency to better improve their QMS as well as their submissions.
Get started and download the checklist.
Most quality teams don’t suddenly decide that their eQMS needs to be replaced. This is an important decision that is...
Most quality teams know that manual inspection prep is inefficient, but what’s harder to define is exactly how inefficient it...
What the RWE Program Is The Advancing Real-World Evidence (RWE) Program is an optional, sponsor-initiated pathway run by the Center...
