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
This QHub Expert White Paper for MedTechs identifies areas that commonly signal weaknesses in Quality Culture, explains strategies for improvement, and provides actionable recommendations for
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 FDA has added AAMI’s CR515:2025, addressing cybersecurity risks unique to machine learning-enabled medical devices, to its list of recognized consensus standards, while cautioning that
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