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.

2021 Spring
Class#SctTypeSeatsUnits
8307 01 Lecture 40 3.00
DaysStartEndLocation
MON TUE WED THU FRI SAT 5:00 PM EST 6:15 PM EST Synchronous Online
Instructor: Jean Mattar Class status:
Prerequisite: BNG 255 or permission of instructor
Enrollment Section
Class instruction mode: On-Line
2021 Spring
Class#SctTypeSeatsUnits
8307 01 Lecture 40 3.00
DaysStartEndLocation
MON TUE WED THU FRI SAT 5:00 PM EST 6:15 PM EST Synchronous Online
Instructor: Lamya Karim Class status:
Prerequisite: BNG 255 or permission of instructor
Enrollment Section
Class instruction mode: On-Line
2021 Spring
Class#SctTypeSeatsUnits
8307 01 Lecture 40 3.00
DaysStartEndLocation
MON TUE WED THU FRI SAT 5:00 PM EST 6:15 PM EST Synchronous Online
Instructor: Tracie Ferreira Class status:
Prerequisite: BNG 255 or permission of instructor
Enrollment Section
Class instruction mode: On-Line

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