The US FDA described in a Town Hall webinar how medical device inspections under the Quality Management System Regulation (QMSR) emphasize a flexible, risk-based approach
At an April 1 Town Hall, the US Food and Drug Administration outlined updates to its medical device inspection approach under the Quality Management System
Three QualityHub subject matter experts discuss the US FDA’s updated Compliance Program Manual for MedTech, which gives medical device manufacturers a roadmap of inspection priorities
With the FDA’s regulatory change from QSR to QMSR for medical devices comes an update of the agency’s Compliance Program Manual (CPM) for the inspection
The FDA replaced its longstanding Quality System Regulation and QSIT inspection framework with a new QMSR rule aligned to ISO 13485, but without providing a
With the introduction of its new Quality Management System Regulation (QMSR), the FDA has transitioned MedTech personnel requirements from QSR Sec. 820.25 to ISO 13485
The US Department of Justice is intensifying enforcement scrutiny of the medical device sector, focusing on, among other things, product quality, failure to report adverse
The FDA’s new Quality Management System Regulation makes quality culture a top management responsibility, and regulators will increasingly look for objective evidence that quality is
The IMDRF has revised its MDSAP audit approach to align with the FDA’s new Quality Management System Regulation, removing references to the former QSR rule
The FDA’s Quality Management System Regulation is now in effect, requiring medical device companies to transition from the legacy QSR rule to a framework aligned