Description
ENGR 414. BIOMEDICAL ENGINEERING DESIGN AND REGULATIONS. This course covers many aspects of medical device development, from idea inception to its delivery to the marketplace. Students will learn about the US FDA regulatory system governing the use of medical devices in the United States, including regulatory pathways and device classifications. Students will analyze and discuss management of risk and the impact of ethics on technology development. Students will evaluate how the regulatory process is involved in device design and clinical studies. Three hours.