Title :
Standards education in senior design courses
Author :
Kunst, Brian S. ; Goldberg, Jay R.
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.
Keywords :
biomedical education; educational courses; product development; project engineering; standards; biomedical engineering senior design courses; companies; design phase; manufacturers; medical device standards; project; standards education; Catheters; Hazards; IEC standards; ISO standards; Management training; Manufacturing; Process design; Product design; Quality management; Testing; Biomedical Engineering; Curriculum; Education, Professional; Equipment Design; Equipment Failure Analysis; Equipment and Supplies; Reference Standards; Teaching; United States;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
DOI :
10.1109/MEMB.2003.1237511