Using quality system regulations and FDA design control guidance as a basis for capstone senior design

Abstract

Medical device development in the industrial setting follows the tenets of Quality System Regulations (QSR) and the design control guidance of the U.S. Food and Drug Administration (FDA). Many biomedical engineers learn the language and practices of QSR and design controls on the job. Experiential learning in these areas gives biomedical engineering graduates a valuable skill set coveted by medical device companies. This skill set will position biomedical engineers apart from other engineering disciplines and will help more completely define the biomedical engineer. The Biomedical Engineering Department at Western New England College has developed an approach to the capstone senior design course which integrates QSR and design controls into the curriculum. This integration uses an experiential method in which students follow the guidelines for design control and QSR, closely mimicking best practices seen in the medical device industry. The idea to incorporate QSR and FDA design control guidance was generated largely through the Department's industrial advisory board. Members of our board from the medical device industry see a knowledge gap in QSR and design control in recent hires from the general pool of engineering graduates. The incorporation of these elements into our capstone design course, not just in theory, but in practice, seeks to alleviate this gap. © American Society for Engineering Education, 2010.