Quality & Compliance
QMSR Explained: Key Changes from FDA QSR to the New Quality Management System Regulation
The FDA's transition from the long-standing Quality System Regulation (QSR, 21 CFR Part 820) to the new Quality Management System Regulation (QMSR) represents one of the most significant regulatory...
Quality & Compliance
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths
The Crossroads of Global Compliance For medical device and diagnostic companies operating in today’s global marketplace, success depends on more than just innovative products — it hinges on a...