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
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
A 31-year FDA veteran and QualityHub VP, Sean Boyd, highlights that MedTech companies face significant challenges preparing for the FDA’s new Quality Management System Regulation
The FDA is preparing for its new Quality Management System Regulation by training investigators on a new inspection model replacing the old QSIT method. This
The FDA urges medical device makers to prepare now for the new Quality Management System Regulation. Though similar to ISO 13485, compliance requires active effort.