A smooth FDA inspection can still collapse at the closeout meeting, QualityHub’s Dan McMinn warns. Issues thought resolved days earlier can resurface as findings, especially
QualityHub experts say the opening minutes of an FDA inspection can set the tone for everything that follows. Consultants Dan McMinn and Anne Albertz outline
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’
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,
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