BNG 528: Med Dev Regs & Regltry Strats

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.

2022 Fall
Class#SctTypeSeatsUnits
11753 01 Lecture 30 3.00
Days Start End Location
MON TUE WED THU FRI SAT 10:00 AM EDT 10:50 AM EDT Textile Building 101
Instructor: Lamya Karim Class status:
Enrollment Section
Class instruction mode: In Person