Medical Device Management and Regulation, Certificate

Certificate in Medical Device Management and Regulation

Medical Device Management and Regulation Certificate prepares students with knowledge and skills required to work in medical device industry. Specifically, students will be able to demonstrate knowledge of medical devices and how they are regulated by ISO  standards, U.S. Food and Drug Administration (FDA), and European Union, risk management standards related to medical device regulatory pathway, good manufacturing practices of medical devices and operations and process improvements in production settings, 510(k) submissions, quality systems, and different stages of project management.

The following information has official approval of The Department of Biomedical Engineering and The College of Engineering and Polymer Science, but is intended only as a guide. Completion of this certificate is contingent upon many factors, including but not limited to: class availability, total number of required credits, work schedule, finances, family, course drops/withdrawals, successfully passing courses, prerequisites, among others.

The following courses constitute a “Certificate in Medical Device Management and Regulation” and must be completed with a minimum grade point average of 2.0 overall for the certificate to be noted on the student’s record.

Summary

Required Courses