Course 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.
Fall 2025
Instructors
Meeting Patterns
Classes Start:
August 18, 2025
Classes End:
December 2, 2025
Location:
02220 Engineering Building 3
Class Days:
T
Class Start Time:
6:00pm
Class End Time:
9:00pm
Class Type:
Lecture and Lab
Credits:
4.00
Restrictions:
Prerequisite: Graduate Standing; R: Restricted to students enrolled in the M.S. Biomedical Engineering - MedTech Innovation and Entrepreneurship Program
