RGA 6650 — Medical Device Product Development in Canada
3 semester hoursGraduateLecture
Explores the requirements for medical device regulation in Canada and globally. Studies Canadian medical device regulations, including establishment licensing and compliance, device licensing, classification, significant change and license amendments, postmarket surveillance, and investigational testing requirements. Explores the use of global standards related to the regulation of medical devices.Familiarizes students with the International Medical Device Regulators Forum’s goals and objectives and explores its medical device regulatory model in use in many countries today.Covers the application of quality management principles to medical device development.Offers students a project-based opportunity to learn how to prepare a sample submission for Canada.