The IMDRF has revised its MDSAP audit approach to align with the FDA’s new Quality Management System Regulation, removing references to the former QSR rule
As the FDA prepares to retire its longstanding Quality System Inspection Technique with the rollout of the new Quality Management System Regulation, QSIT creator and
The FDA’s Quality Management System Regulation, effective Feb. 2, replaces the agency’s traditional Design Controls with ISO 13485–aligned Design and Development activities, marking a significant
With the FDA’s Quality Management System Regulation coming into force on Feb. 2, medical device makers face heightened pressure to strengthen risk management practices as
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