TE1054 - Medical Device Quality Assurance & Regulatory Affairs

Course Description

Medical Device Regulatory Affairs is a course that provides a comprehensive and easy to understand overview ofcurrent FDA regulatory compliance with respect to developing and marketing medical devices. The course presentsrelevant aspects of FDA regulations and the practical aspects of bringing a medical product to market, including the 510(k) process (pre-market submission made to the FDA to demonstrate that the device to be marketed is safe and effective) and pre-market approval (PMA) processes (scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices). The course also covers Good Manufacturing Practices (GMP) concepts, medical device registration, listing, reporting, and outlook for the future.