Regulatory Sciences
Top 7 QMSR Readiness Gaps Medical Device Manufacturers Should Assess Before an FDA Inspection
FDA's New Quality Management System Regulation Raises the Bar for Inspection Readiness FDA's Quality Management System Regulation (QMSR), which became effective on February 2, 2026, represents one of...
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...