BNG 428: Med Dev Regs & Regltry Strats - fall

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.

2023 Fall
Class#SctTypeSeatsUnits
11422 01 Lecture 40 3.00
Days Start End Location
MON TUE WED THU FRI SAT 10:00 AM EDT 10:50 AM EDT Textile Building 101
Instructor: Qinguo Fan Class status:
Prerequisite: BNG 255 or permission of instructor
Enrollment Section
Class instruction mode: In Person