Certificate in Regulatory Affairs in Medical Devices

The certificate has several goals:

1. Provide curricular guidance to undergraduate students on careers in the regulatory affairs field for medical devices.  
2. Provide curricular guidance for understanding regulatory affairs requirements and processes related to medical device design, development and manufacture for students entering medical device industry, governmental agencies, or pursuing entrepreneurship opportunities.
3. Provide additional credentialling that builds on B.S. degree in engineering and technology programs.

Learning Outcomes:

1. The student will recognize and understand FDA regulatory nomenclature.
2. The student will understand the federal regulations and quality standards in the approval process of a medical device.
3. The student will be able to understand and use regulatory application and report forms.
4. The student will be able to identify and navigate the basic regulatory steps in the development process for medical devices.
5. The student will be able to identify basic responsibilities of the regulatory affairs processional that extend throughout the lifetime of medical device.
6. The student will be able to understand the fundamental elements of the Quality Management System (QMS) required for all medical device manufacturing companies.
7. The student will receive an overall understanding of the role of regulatory affairs in the medical device industry, from the selection of raw materials to the manufacturing and product release of finish goods.

Required Courses:

Total credits: 13

• BIOM 4340 - Manufacturing Processes Credit Hours: 3
• BIOM 4806 - Regulatory Affairs of Medical Devices Credit Hours: 3
• TECH 4462 - Quality Improvement Credit Hours: (3)
• BIOM 4730 - Biomaterials Credit Hours: (4)