Stephanie Slater

Feb 5, 2024 | lexology.com | Deeona Gaskin |Raj Pai |Daniel Roberts |Stephanie Slater

The U.S. Food and Drug Administration (FDA) issued long-awaited revisions to the current good manufacturing practice (CGMP) requirements for finished medical devices on January 31, 2024. These revisions are now known as the Quality Management System Regulation (QMSR). Importantly, the rule amends 21 C.F.R. Part 820 by aligning more closely to the International Organization for Standardization (ISO)13485:2016 requirements, which are used by many regulatory authorities outside of the United States.

May 3, 2023 | militarynews.com | Stephanie Slater

May 1, 2023 | dvidshub.net | Stephanie Slater

Apr 20, 2023 | militarynews.com | Stephanie Slater

Apr 13, 2023 | dvidshub.net | Stephanie Slater