Program: Biomedical Regulatory and Quality Science Certificate - Clemson University

2023-2024 Graduate Catalog

Apr 02, 2025

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

‌

Colleges

Academic Resources

Outside the Classroom

Applying to Clemson

Academic Opportunities

Financial Aid

Join Your Clemson Family

Services On Campus

Get Involved

Research Opportunities

Public Service and Agriculture

Innovation and Economic Development

For Tigers

Campus Resources

Campus Leadership