Medical Device Regulatory Affairs is a course that provides a comprehensive and easy to understand overview of current 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. After completing Medical Device Regulatory Affairs, students will be equipped with a basic understanding of the following: No prior experience or coursework required. Students will be assigned 5 homework assignments, and 1 final exam for each course. Introduction Medical Device Classifications 510(k) Clearance to Market PMA (Pre-Market Approval) Good Manufacturing Compliance (GMP) Compliance Medical Device Registration, Listing, & Reporting Medical Device Outlook This course is Instructor-led and delivered through our award-winning online Learning Management System.