BNG 428: Med Dev Regs & Regltry Strats - fall

Prerequisite: BNG 255 or permission of instructor

This course is a discussion of design of biomedical engineering devices and systems, laws and regulations applied to medical product 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 regulations based on the US FDA requirements.