BMA 503 - Reg Aspects Medical Prod

This course is designed for graduate students and advanced education clinicians who plan careers in the medical products industries, either as research scientists/engineers or as consulting clinicians. The course covers U.S. and international regulatory requirements for medical products, as applied to bench research, animal testing, clinical testing, manufacturing, sterilization, and post-market surveillance. Our purpose is to review 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 medical product development, production, and use in the U.S. and other major markets in the world.

Credits: 2