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
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’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 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
As the FDA prepares to retire its longstanding Quality System Inspection Technique with the rollout of the new Quality Management System Regulation, QSIT creator and
The FDA’s Quality Management System Regulation, effective Feb. 2, replaces the agency’s traditional Design Controls with ISO 13485–aligned Design and Development activities, marking a significant
With the FDA’s Quality Management System Regulation coming into force on Feb. 2, medical device makers face heightened pressure to strengthen risk management practices as