Recorded April 13, 2022 | On-Demand Webinar
Determine when an investigational device exemption (IDE) is needed. Learn the components of Institutional Review Boards (IRBs). Recognize the requirements elements of informed consent. Understand the responsibilities of a clinical trial sponsor. Learn what bioresearch monitoring (BIMO) looks for in a clinical trial inspection.
This session was recorded as part of FDLI’s virtual Introduction to Medical Device Law and Regulation course in April 2022.