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
An FDA investigator emphasizes the critical importance of supplier oversight in medical device manufacturing, warning that poor control remains a common inspection issue. Manufacturers must
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.