Regulatory, Quality, and Safety Issues in Bioengineering credit: 3 or

4 Hours

Overview of regulatory agencies involved in approval of medical products. Approaches to quality engineering including safety and risk analysis for medical products. Students will learn from case studies of medical product approvals and perform risk analysis for medical products. 3 undergraduate hours. 4 graduate hours. Credit is not given toward graduation for: BIOE 470 and either BIOE 498 RI or BIOE 598 RI. Prerequisite: BIOE 400 completion or concurrent enrollment.