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.
| 2023 Fall | ||||||||
|---|---|---|---|---|---|---|---|---|
| Class# | Sct | Type | Seats | Units | ||||
| 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: Lamya Karim | Class status: O | |||||||
| Prerequisite: BNG 255 or permission of instructor | ||||||||
| Enrollment Section | ||||||||
| Class instruction mode: In Person | ||||||||