FDA Regulation of Medical Devices

Prerequisites: BME 301. Restrictions: none. The course will teach the FDA regulatory process including design documentation and quality management system to attain FDA approval for medical devices. Statistical tests for the development of human randomized clinical trials and non-clinical bench testing of medical devices will be taught with safety standards for medical devices. A project will be assigned to teach students how to apply for FDA approval for a student-selected medical device.

Term 202410 #16227 BME472
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Instructor
Meeting Times
Online Course or no set meeting time
Enrollment

19

seats available

21

currently enrolled

40

maximum enrollment

99

waitlist seats available

99

waitlist capacity

Section Tally

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