One year after RIFs, the FDA has stabilized operationally but faces a prolonged challenge in rebuilding lost institutional knowledge and expertise, according to former official
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
A QualityHub SME says medical device companies must move beyond treating risk management as a compliance exercise and instead adopt dynamic, continuously updated approaches informed
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 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