About this Course

Knowledge in regulatory requirements plays a critical role in ensuring compliance with the laws and regulations guiding the development and commercialization of health care products. As medical technology and bioscience companies grow and mature, their need for trained regulatory personnel intensifies. Developed and taught by experienced personnel from the certification industry, this module aims to provide a broad regulatory foundation, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the medical technology industry. Throughout the course, the instructors will make learning more engaging with relevant examples and hands-on exercises. It offers students an opportunity to demonstrate an appreciation of the subjective and interpretive aspects of the regulations and an ability to think critically about the interaction between regulatory and development processes.

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