´ó·¢²ÊƱƽ̨

important

Note: ´ó·¢²ÊƱƽ̨’s new Course Catalogue will replace the eCalendar. The Course Catalogue is expected to go live the week of April 22nd. When the new site is published, "mcgill.ca/study" will be redirected to the new Course Catalogue website.

Course information on this site is not reflective of offerings for the 2025–2026 academic year. Some irregularities may occur as we move operations to the incoming Course Catalogue.

BMDE 654 Biomedical Regulatory Affairs - Medical Devices (3 credits)

Offered by: Biomedical Engineering (Faculty of Medicine and Health Sciences)

Administered by: Graduate Studies

Overview

Biomedical Engineering : 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: Fall 2024, Winter 2025

Instructors: Kroo, Danny (Fall) Kroo, Danny (Winter)

Back to top