BIOE 498 RI - Special Topics - Regulatory and Safety Issues
Subject offerings of new and developing areas of knowledge in bioengineering intended to augment the existing curriculum. See Class Schedule or departmental course information for topics and prerequisites. Course Information: 1 to 4 undergraduate hours. 1 to 4 graduate hours. May be repeated in the same or separate terms if topics vary to a maximum of 12 hours, but no more than 8 in any one term.
Overview of regulatory agencies involved in approval of medical products. Approaches to safety and risk analysis for medical products. Students will learn from case studies of medical product approvals and perform risk analysis for medical products. Prerequisite: BIOE 435 and BIOE 436 completed or concurrent enrollment.
Option 1Number of Required Visit(s): 0
Course Level: Graduate