Biomedical engineers are uniquely involved in many aspects of product development, from the inception of the idea to its delivery in the marketplace. This course will cover one major aspect of that process—the objectives and mechanisms of the FDA regulatory system governing the clinical use of medical devices in the United States, including regulatory pathways and device classification. Students will both analyze and discuss management of risk, and they will design controls related to cardiovascular, orthopedic, and neurological devices. By the end of the course, students will have a deep understanding of how the regulatory process is involved in every phase of medical device development.

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