National University




BET404 Medical Device Compliance

Lead Faculty: Dr. Peilin Fu

Course Description

Overview of medical device safety and applicable regulations including broad themes in medical device surveillance. Discussion of various regulatory agencies and how they oversee the various safety and regulatory aspects related to medical devices.

Learning Outcomes

  • Demonstrate regulatory knowledge with regard to medical devices permitting and operation.
  • Develop safety plans for the operation of medical devices used in clinical application.
  • Acquire sufficient knowledge of fundamental physical principles related to the safety of medical devices.
  • Evaluate specific unsafe practices in the operation of medical devices.