Regulatory Affairs for Medical Devices

BIOENGR X 430.2

This course introduces and reviews the role of Regulatory Affairs (RA) in the medical device industry.

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What you can learn.

  • Describe the role of Regulatory Affairs (RA) in the medical device industry and its history
  • Define the U.S. and the European Union (EU) regulatory processes, and an overview on Canada and Japan
  • Describe the various regulatory agencies and how to access RA information including medical device submissions, Quality System Regulations (QSR), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and EU and FDA inspections procedures
  • Implement strategies to get products to market quickly and in a safe and efficacious fashion

About this course:

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 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 will primarily focus 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 will also include strategies to get products to market quickly and in a safe and efficacious fashion. Required course in the Medical Device Engineering Certificate.

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This course applies towards the following certificates & specializations…

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