BMDE 654. Biomedical Regulatory Affairs - Medical Devices.
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BMDE 654
Biomedical Regulatory Affairs - Medical Devices.
Credits: 3
Offered by: Biomedical Engineering (Graduate Studies)
This course is not offered this catalogue year.
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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