Learn how medical device manufacturers are required to evaluate and report post-market adverse events and product problems. Recognize when to conduct a recall and how corrections and removals are reported to the FDA. Understand how medical device manufacturers are required to monitor device performance following clearance or approval.
Véronique Li, Senior Medical Device Regulation Expert, Hyman Phelps & McNamara, PC
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in November 2022.