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BMDE 654 Biomedical Regulatory Affairs - Medical Devices (3 unit茅s)

Offered by: G茅nie biom茅dical (Facult茅 de m茅decine et des sciences de la sant茅)

Administered by: 脡tudes sup茅rieures et recherch

Vue d'ensemble

G茅nie biom茅dical : 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.

Terms: Automne 2022

Instructors: Kroo, Danny (Fall)

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