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Capstone Design Courses, Part IIIncorporating Design Controls

Capstone Design Courses, Part II: Incorporating Design Controls [At the September 2007 meeting of the Biomedical Engineering Innovation, Design, and Entrepreneurship Alliance (BMEidea), incorporating design controls into the biomedical engineering design curriculum was discussed. Most attendees (capstone design instructors) agreed that this was an important topic to introduce to our students. Other attendees expressed the feeling that design controls were “a bunch of nonsense” and that students could learn about them on the job, making it unnecessary for instructors to include them in the design curriculum. I feel that design controls comprise an important knowledge area with which our students should be familiar prior to working in industry. They are an important tool intended to control, provide structure to, and improve the design process and the quality of new medical devices introduced to the public. Our students and industrial stakeholders benefit when we provide our students with an exposure to not only design controls, but other regulatory aspects of medical device design such as pathways to marketing a medical device (510(k)’s, PMA’s, etc.), rules for conducting an animal or human clinical study, risk management, Institutional Review Boards, Quality Systems Regulations, ISO 9000, and other medical device standards.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Capstone Design Courses, Part IIIncorporating Design Controls

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Publisher
Springer International Publishing
Copyright
© Springer Nature Switzerland AG 2012
ISBN
978-3-031-00524-4
Pages
25 –28
DOI
10.1007/978-3-031-01652-3_7
Publisher site
See Chapter on Publisher Site

Abstract

[At the September 2007 meeting of the Biomedical Engineering Innovation, Design, and Entrepreneurship Alliance (BMEidea), incorporating design controls into the biomedical engineering design curriculum was discussed. Most attendees (capstone design instructors) agreed that this was an important topic to introduce to our students. Other attendees expressed the feeling that design controls were “a bunch of nonsense” and that students could learn about them on the job, making it unnecessary for instructors to include them in the design curriculum. I feel that design controls comprise an important knowledge area with which our students should be familiar prior to working in industry. They are an important tool intended to control, provide structure to, and improve the design process and the quality of new medical devices introduced to the public. Our students and industrial stakeholders benefit when we provide our students with an exposure to not only design controls, but other regulatory aspects of medical device design such as pathways to marketing a medical device (510(k)’s, PMA’s, etc.), rules for conducting an animal or human clinical study, risk management, Institutional Review Boards, Quality Systems Regulations, ISO 9000, and other medical device standards.]

Published: Jan 1, 2012

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