As makers of medical devices expand their use of AI to generate SOPs and other controlled documents, the focus is shifting from content creation to
In this QualityHub Brief, pharma companies are introduced to the unique regulatory and manufacturing challenges associated with developing combination products, even when using standard delivery
FDA officials at MedCon 2026 said the agency’s new medical device inspection framework under the Quality Management System Regulation builds on the legacy of the
At MedCon 2026, FDA official Barb Marsden acknowledged growing strain on medical device review timelines driven by staffing shortages and MDUFA-related workload pressures, while stakeholders
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