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
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