Medical Device Product Development in Canada

Catalog description

Explores the general requirements for medical device regulation globally and the details of medical device regulation in Canada. Familiarizes students with the International Medical Device Regulatory Forum goals and objectives, and explores the medical device regulatory model developed by Global Harmonization Task Force that is in use in many countries today. Studies the Canadian medical device regulations, covering topics such as postmarket topics of adverse event reporting, recalls and inspections, classification, device licensing, establishment registration, design change, license amendments, and annual renewal processes. Explores the use of standards globally and in Canada related to the regulation of medical devices. Offers students a project-based learning opportunity to learn how to prepare portions of a sample submission for Canada.