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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.

Introduction According to the 2009 AIMBE biomedical engineering placement survey, 49% of bachelor-level graduates obtained employment in industry.1 The U.S. Department of Labor projects an employment growth rate of 72% for biomedical engineers in the decade 2008-2018. This growth rate is much faster than for other engineering disciplines.2 Reasons for this projected rapid increase include the demand for more technically sophisticated medical devices due to an aging population, and concern for the development of more cost effective medical procedures.2 This increased demand coupled with an existing trend of engineers going to the medical device industry necessitates a change in the academic setting to better prepare and train these engineers for careers in biomedical device and related industries. The objective of this

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Gettens, R., & Rust, M., & Testa, D., & Cezeaux, J. (2010, June), Using Quality System Regulations And Fda Design Control Guidance As A Basis For Capstone Senior Design Paper presented at 2010 Annual Conference & Exposition, Louisville, Kentucky. 10.18260/1-2--15903