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Regulatory Aspects of Medical Devices

Course ID#: MFC 448

Credits: 3

Course Description:

This course is designed for students who plan to develop a career in the life sciences products industry. The course will cover U.S. and international regulatory requirements for medical devices and drugs, as applied to bench research, animal testing, clinical testing, manufacturing, sterilization, and post-market surveillance. Our purpose is to present key regulatory concepts and practical applications that will enable you to understand the historical context of medical product regulations and to have a working knowledge of the current requirements placed on product development, manufacturing, and use in the U.S. and other major markets in the world. LEC

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