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
The FDA’s Quality Management System Regulation is now in effect, requiring medical device companies to transition from the legacy QSR rule to a framework aligned
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
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
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
Former FDA investigator Lori Carr and Alson & Bird litigation attorney Dan Jarcho share their memories of US v. Utah Medical Products, a landmark GMP
Medical device manufacturers must rigorously identify and handle customer feedback as potential Medical Device Reports (MDRs) to avoid regulatory risks, especially amid the rising trend
MedTech manufacturers must carefully evaluate whether device modifications, especially software updates, require new FDA pre-market authorization to avoid compliance issues during inspections. Additionally, companies should
Clear traceability between design inputs and outputs is crucial for MedTech manufacturers to meet FDA and ISO 13485 requirements and avoid inspectional observations. Properly documented