Regulatory Affairs for Medical Devices Course

Program Overview

This engineering course provides an overview of Regulatory Affairs (RA) in the medical device industry, covering regulations, standards, and best practices for product development and post-approval monitoring. It includes topics such as RA history, regulatory agencies, medical device submissions, quality systems, and inspections. The course aims to equip students with the knowledge and skills to navigate the RA environment and bring medical devices to market safely and efficiently.

Program Outline

Outline:

This engineering course introduces and reviews the role of Regulatory Affairs (RA) in the medical device industry. The RA environment encompasses the regulations and standards governing product development, from its infancy through post-approval monitoring. 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.