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BMDE 654. Biomedical Regulatory Affairs - Medical Devices.

Credits: 3
Offered by: Biomedical Engineering (Graduate Studies)
Terms offered: Fall 2026
View offerings for Fall 2026 in Visual Schedule Builder.

Description

Regulatory strategies and quality management systems are critical for medical device development. This course provides an overview of regulatory requirements, and familiarize students with the important ISO and IEC standards pertaining to medical device development. This course will provide biomedical engineers with an understanding of the regulatory and quality requirements to translate a medical device idea into a commercial product, and will draw upon the expertise of invited speakers currently working in the medical devices industry.

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