University at Buffalo 3 credits Biomedical Engineering
This course provides biomedical engineering students with an in-depth understanding of the regulatory landscape for medical devices and pharmaceuticals, focusing on FDA regulations. The course will cover U.S. and international regulatory requirements for medical products. This course will present key regulatory concepts and practical applications that will enable students to understand the historical context of medical product regulations and have a working knowledge of the current requirements placed on development, production, and use in the U.S. and other major markets in the world.
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