BE 3180. INTRODUCTION TO MEDICAL DEVICE REGULATORY REQUIREMENTS AND QUALITY STANDARDS. 1 Hour.
Topics include introduction to fundamentals of regulatory requirements for medical devices, broadly defined as mechanical and electronic equipment or tissue-implantable constructs. Familiarization with national and international regulatory agencies, and presentation of the processes of securing regulatory approvals for medical devices. Emphasis will be on the U.S. Food and Drug Administration, but examples from other regulatory agencies will also be presented. The course also introduces students to the U.S. National Institute of Standards and Technology as well as various professional engineering societies that provide quality standards for bioengineering design. Prerequisite: Accepted into the BE Professional Program or consent of the BE undergraduate advisor.