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
The FDA’s Karen Cruz-Arenas says weak or nonexistent internal audit activities are a recurring QMSR-related inspection observation, with some MedTech companies incorrectly assuming that an
Early FDA inspection data under the new QMSR framework points to persistent weaknesses in how companies manage risk, oversee suppliers, investigate complaints, maintain UDI compliance,
A strong Culture of Quality in medical device companies is demonstrated through leadership actions and employees’ willingness to raise concerns, among other factors, rather than
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
QualityHub has appointed medical device quality executive Christina Arnt as Vice President of Medical Device Compliance. Arnt brings extensive global quality systems leadership experience from
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