Standards education in senior design courses.

Abstract

Medical device standards provide many benefits to manufacturers and users of medical devices. Compliance with these standards is necessary to allow companies to market their devices. Standards contain requirements that affect the way medical devices are designed, developed, and tested. Students in biomedical engineering senior design courses need to be made aware of these standards and understand their impact on the design process for medical devices. They need to appreciate the value of considering them early in the design phase of a project. This article discusses how medical device standards education can be incorporated into senior design courses.