BIOE489U

Special Topics in Bioengineering; Medical Device Development and the Regulatory Process

Prerequisites: BIOE120, BIOE121, BIOE241, and MATH246. Provides an overview of the commercial development pathways for both pharmaceuticals and medical devices, from inception to market. Class topics will include identifying technological needs, concept generation and invention, intellectual protection, licensing, risk management, preclinical, clinical, good manufacturing practices, global regulatory issues, marketing factors, and post marketing surveillance which influence discovery and development of new medical products.

Sister Courses: BIOE489A, BIOE489B, BIOE489C, BIOE489D, BIOE489F, BIOE489G, BIOE489H, BIOE489I, BIOE489J, BIOE489K, BIOE489M, BIOE489N, BIOE489O, BIOE489P, BIOE489Q, BIOE489R, BIOE489T, BIOE489V, BIOE489W, BIOE489X, BIOE489Y, BIOE489Z

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