Abstract

ISO 9001 requires a company's product design and development process to include specific components [1]. These include design and development planning, design input, design output, design review, design verification and validation, and design transfer. The more our students become familiar with each of these components, the better prepared they will be for careers in the medical device industry. Ideally, capstone design projects would involve each of these components. In situations where this is not possible, lectures regarding the details of each design control component can be included in the capstone course.

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