A CAPA is only as defensible as the evidence behind it. QualityHub SVP Rebecca Fuller explains why Verification of Effectiveness planning should begin with the
Jennifer Maandi’s lifelong interest in language has shaped a career in medical device quality, where communication, interpretation, and attention to detail are essential. Now joining
During a July 22 Town Hall webinar, FDA officials said their new human factors guidance applies only to marketing submissions and doesn’t change MedTech manufacturers’
This QualityHub Expert Brief examines the evolution of training requirements for makers of medical devices, highlights key differences between FDA’s former Quality System Regulation (QSR)
This QualityHub Expert White Paper examines the regulatory foundations, operational principles, and implementation practices associated with effective CAPA systems within the medical device industry. Particular
Despite FDA staffing changes, the agency’s medical device review performance remains strong, according to former FDA leader and current QHub Corporate VP Sean Boyd, who
As the FDA’s QMSR places greater emphasis on risk-based decision-making, medical device manufacturers are expected to align CAPA investigations with the potential impact on product
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