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
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
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
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
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 introduction of its new Quality Management System Regulation (QMSR), the FDA has transitioned MedTech personnel requirements from QSR Sec. 820.25 to ISO 13485