Regulatory Affairs

4 credits

Introduces real-world tools and skills that product development engineers are expected to master in a medical device company. Students will be introduced to all stages of medical device development in an FDA-regulated environment with an emphasis in design controls and building a design history file. Students will also be exposed to other relevant topics such as project management, legal consideration, medical reimbursement, regulatory submissions, commercialization, and product improvements. Prerequisites: graduate standing in bioengineering only or consent of department.