BME1801H Medical Device Regulation: Hardware, Software & AI

Streams

Clinical Engineering

Sessions

Fall

Description

The objective of this course is to provide students with the regulatory requirements to which a medical device intended for clinician use must comply.  A top-down approach will be taken where the regulatory path for market authorization along with the product development and validation are reviewed for different types of devices. Students will be required to use their existing knowledge of biomedical engineering and knowledge obtained in the course to establish plausible regulatory pathways and supporting non-clinical and clinical validation requirements for a range of medical devices including implantable devices, artificial-intelligence based devices, software devices, and in-vitro diagnostic devices.  The discussion model will focus mostly on the United States regulatory office with some comments on Canada and Europe. This course focuses on products currently for sale as case studies, or may be approved for sale within the next two years consistent with its practical commercial focus.

Old course title: Biomedical Product Development II

Prerequisites

MSE352 Biomaterials and Biocompatibility or equivalent. Equivalency will be assessed by the course instructor and determined on an individual basis.

Components

Lecture

The BME1801 course is a parallel course to the BME460 course taught to Engineering Science students, and the students will take several courses together. However, BME1801 students will have their own group project teams.

Restrictions

MEng students only (not suitable for PhD or MASc students)