BME 5530
Computerized Systems in Medical Technology Life Cycle
Cornell University · UGRD · Fall 2026
Catalog description
Medical technology innovation is one of today’s most exciting—and challenging—fields. Society demands breakthroughs that are faster, better, and more affordable, while the industry navigates complex regulations, diverse stakeholders, and rigorous quality standards. Success requires mastering the balance of quality, speed, cost, and value—where value means delivering better clinical outcomes and patient experiences at lower cost. In this course, you’ll discover how computerized systems play a critical role throughout the medical technology product life cycle. You’ll gain both the theory and hands-on skills behind Automated Test and Measurement Systems—and see how they are applied from ideation to production. This course is part of the Cornell BME MEng specialization in Medical Technology Quality and Systems, preparing you to lead the next wave of innovation. This course requires a comprehensive understanding of the medical technology product development life cycle, including the Biodesign framework, Agile methodologies, FDA regulations, ISO standards, and quality system management principles specific to medical technology.
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