Medical Device Design, Recycling and Reprocessing Certificate

Program Description

Medical device “reprocessing” involves the cleaning, disinfection, and sterilization of medical devices and healthcare products after each use. Reprocessing is recognized as one of the top 10 regulatory science priorities by the U.S. Food and Drug Administration and is an essential practice in healthcare delivery.

The Medical Device Design, Recycling and Reprocessing Certificate is an internship immersion program that prepares students for careers in the fast-growing global medical device industry. It provides an educational program that aims to train engineers to optimize medical device designs for sustainability in healthcare, to gain skills in reprocessing validation methods for industry while maintaining regulatory compliance, and to develop medical device commercialization strategies.

More information is available at https://www.clemson.edu/cecas/departments/bioe/academics/certificate.html.

Summary of Certificate Requirements

The Certificate consists of a five-course sequence (15 credits) of graduate-level Bioengineering courses taught by multi-disciplinary faculty and industry professionals. Courses are open to graduate students (BS/MS, MS, MEng, PhD) enrolled in any engineering discipline. Several courses overlap with the Technology Entrepreneurship Certificate at the Spiro Institute and the Quality Science Professional Certificate offered through Bioengineering.

Coursework

• BIOE 6380 - Engineering Controls and Validation for Microbiological Systems 3 Credits  
• BIOE 8140 - Medical Device Commercialization 3 Credits  
• BIOE 8150 - Design, Manufacturing and Validation Methods for Reusable Medical Devices 3 Credits  
• BIOE 8620 - Pre-Clinical Assessment and Regulatory Affairs for Medical Devices 3 Credits  or BIOE 8630 - Regulatory and Clinical Affairs for Medical Devices 3 Credits  
• BIOE 8900 - Bioengineering Internship 1-6 Credits  (3 Credits required)