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
One year after RIFs, the FDA has stabilized operationally but faces a prolonged challenge in rebuilding lost institutional knowledge and expertise, according to former official
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