BME 5110 - Regulatory Affairs I

Institution:

University of Utah

Subject:

Biomedical Engineering

Description:

This course is designed to help students succeed in the biomedical industry by providing students with a solid understanding of current government regulations and how to apply them. This course places special emphasis on US medical device regulations. The course stresses the practical, hands-on, project-based learning by analysis of real-world case studies, preparation of actual regulatory submissions, and communication with industry professionals. This is a stand-alone course and does not require continuation in Regulatory Affairs II - Drugs, Biologics, and Combination Products.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.utah.edu

Phone Number:

(801) 581-7200

Regional Accreditation:

Northwest Commission on Colleges and Universities

Calendar System:

Semester

General Education

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