PSM-620 Regulatory Science for Medical Product Development (3)

Provides students with an understanding of the regulatory framework governing medical product development and the science used to approve medical products in the United States. Emphasis is placed on the requirements and science for monitoring medical product safety and efficacy in the post-market environment. The role of medical product regulation in the context of global product development is also addressed. Usually offered every spring. Grading: A-F only.
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