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
An effective CAPA system is critical for MedTech manufacturers to meet FDA and ISO requirements and avoid costly compliance failures. This article outlines five expert
Effective management control is essential for medical device companies, as FDA views executive leadership as ultimately responsible for quality system performance and many deficiencies stem
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
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