This QHub Insights article explores why effective communication is one of the most critical, yet often overlooked, elements of FDA inspection readiness. It explains how
In this QHub Insights article, QualityHub experts explain why a well-organized “back room” is essential to a successful FDA inspection, serving as the operational hub
This QualityHub Brief examines how effective management control serves as the foundation of a strong medical device Quality Management System. It explores the role of
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