Regulatory Affairs for Medical Devices

This engineering course is designed to introduce and review the role of Regulatory Affairs (RA) in the medical device industry. The RA environment embraces the regulations and standards governing product development, from its infancy through post-approval monitoring. In today's regulatory environment, products may be classified as biologics, drugs, medical devices or a combination of the former products. In most worldwide countries, each type of product is regulated by a different RA authority and often has its own distinct regulations. This course primarily focuses on the U.S. and the European Union (EU) regulatory processes (although other countries such as Canada and Japan will be briefly reviewed). Course topics include RA history, the various regulatory agencies, accessing RA information, medical device submissions, Quality System Regulations (QSR), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and EU and FDA inspections. It also includes strategies to get products to market quickly and in a safe and efficacious fashion. Required course in the Medical Device Engineering Certificate.