Biomedical Regulatory and Quality Science Certificate

Program Description

The Biomedical Regulatory and Quality Science Certificate is aimed at providing students with a working knowledge of the government regulations and quality systems that govern the development and commercialization of safe and effective medical devices and pharmaceuticals. The certificate helps address a growing need within the medical device and pharmaceutical industries, as well as government agencies (The U.S. Food and Drug Administration), by developing regulatory and quality experts to support their respective enterprises.

Summary of Degree Requirements

The certificate is a 14 credit hour, online graduate certificate comprised of five courses.

Coursework

• BIOE 8620 - Pre-Clinical Assessment and Regulatory Affairs for Medical Devices 3 Credits
• BIOE 8630 - Regulatory and Clinical Affairs for Medical Devices 3 Credits
• BIOE 8660 - Global Regulatory and Legal Requirements of Quality for the MedTech Industry 3 Credits
• BIOE 8670 - Product Development and Validation for the MedTech Industry 3 Credits
• BIOE 8680 - Medical Technology Risk and Failure Analysis 2 Credits