BIOMEDICAL ETHICS & REGULATORY AFFAIRS

Catalog description

This course provides an overview of the ethical and regulatory affairs applied to biomedical engineering. The course covers ethics and Biomedical engineering practice and research, theories and principles of ethics, the code of ethics, ethical considerations in areas including clinical engineering, human enhancement, and implants. This course also covers medical devices and FDA regulatory requirements including medical device design control, review, testing, pre- and post-marketing and compliance. Prerequisite: BMED4500 (2 credits)