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
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,
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
CDRH Director Michelle Tarver says the FDA is advancing a major push toward at-home healthcare as chronic disease rates rise, provider shortages grow, and medical
FDA official Josh Nipper warned medical device companies at MedCon that they remain fully accountable for the accuracy and integrity of all data submitted for
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