BME 511 - Regulatory Affairs I

This course is designed to help students succeed in the biomedical industry by providing students with a solid understanding of current government regulations and how to apply them. This course places special emphasis on US medical device regulations. The course stresses the practical, hands-on, project-based learning by analysis of real-world case studies, preparation of actual regulatory submissions, and communication with industry professionals. This is a stand-alone course and does not require continuation in Regulatory Affairs II - Drugs, Biologics, and Combination Products.