Five FDA officials answer questions from medical device manufacturers about the agency’s Quality Management System Regulation, or QMSR, which goes into force for industry on
The FDA’s new Quality Management System Regulation, effective Feb. 2, will allow the agency to review a medical device manufacturer’s internal and supplier audit findings
The FDA’s recent warning letter to a wearable technology company signals that the agency may heighten scrutiny of devices offering features such as blood-pressure estimation
Industry experts highlight the importance of regulatory, quality, and marketing teams working together to ensure truthful medical product advertising. They also emphasize that regulatory oversight
Former FDA officials urge ex-agency employees to leverage and translate their regulatory experience into business terms when seeking private-sector roles. They stress that combining FDA
QualityHub Principal Consultant Jaime Santana has seen his fair share of strange FDA inspection scenarios over the many years he’s spent in the MedTech and
Following a sweeping Reduction in Force (RIF) that displaced thousands of US government employees, including many at the FDA, former agency officials are navigating new
A veteran MedTech leader has demonstrated exceptional skill in maintaining manufacturing continuity through some of the world’s most challenging supply chain disruptions. Through decisive action,
Medical device manufacturers operating in the highly regulated MedTech sector should engage proactively and strategically with the FDA, advises Sean Boyd, QualityHub’s corporate VP and
QualityHub regulatory expert Rebecca Fuller will lead key sessions at KENX’s MedTech and GMP University, offering practical guidance on risk management, DHFs, post-market surveillance, and