BNG 428: Med Dev Regs & Regltry Strats

Prerequisite: BNG 255 or permission of instructor

Discussion of the laws and regulations applied to medical products development, manufacturing, testing, marketing, and post-marketing surveillance. This course provides an overview of regulatory affairs related to biomedical devices and a foundation to understand the differences in regulations between countries with a focus on the US FDA requirements. This course also teaches risk management about medical products.

Course information

3.00 credits
Section 01: Undergraduate Lecture
Class: #8307

Tue, Jan 19, 2021 - Wed, Apr 28, 2021


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