BME 5530

Computerized Systems in Medical Technology Life Cycle

Course Description

Course information provided by the 2025-2026 Catalog.

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.

Prerequisites BME 5500.

Enrollment Priority Enrollment limited to: BME MEng students.

Last 4 Terms Offered (None)

Learning Outcomes

• Analyze and apply the role of computerized systems across all phases of the medical technology product life cycle, from concept to manufacturing activities.
• Demonstrate proficiency in computational models, programming fundamentals, programming languages, computational nodes, operating systems, and the integration of data acquisition and instrumentation systems for design, verification, validation, and manufacturing control.
• Interpret and apply relevant regulations and standards governing computerized systems in the medical technology sector to ensure compliance and quality.

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