BMEN 469: Entrepreneurial Pathways in Medical Devices

Course Description

Credits 3.
3 Lecture Hours.Overview of fundamental elements and development steps for an effective strategy pathway including regulatory pathway for commercialization of medical product/medical device innovations; application of the basic regulations and associated requirements and enforcements for product market approval; exploration of product quality test method design requirements; understanding of the applicable regulations and standards pertaining to the design, testing, approval and marketing of medical devices.Prerequisite:Admitted to major degree sequence (upper-level) in biomedical engineering.