Medical Device Regulations

1 Unit · Graduate

Provides an analysis of global medical device development and approval requirements, concentrating on the preparation of global medical device strategies. Covers the medical device classification and regulation by ministries of health around the world. FDA regulation of medical devices including Investigational Device Exemption (IDE), 510(k), and PMA will be taught as a foundation for looking at global regulatory submission pathways. In addition to FDA regulations, covers medical device regulations for the European Union, Canada, and other major markets. Students will be exposed to common post-market challenges such as change control and import/export issues.