MedTech Innovation and Entrepreneurship II - Design and Regulation

Catalog description

This course teaches path-to-market concepts including regulatory aspects unique to medical devices and pharmaceuticals. Topics include detailed analyses of Phase I-IV clinical trials, 510(k) and PMA approvals, Investigational Device Exemption (IDE) Investigational New Drug (IND) application, Good Laboratory Practices (GLP) and clinical research organizations (CROs). Students will participate in frequent visits to local biotech companies. Guest lectures will feature experts in FDA processes, clinical research and early stage biotech ventures.