2025-2026 GRADUATE CATALOG {Editing in Progress}
Regulatory Affairs in Medical Devices Graduate Certificate
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The Certificate in Regulatory Affairs in Medical Devices will provide education and knowledge in the regulatory processes needed to help facilitate the design, development, manufacture, commercialization and marketing of safe and effective medical devices by medical device manufacturers and to pursue career as a regulatory professional. The goals for the certificate are to provide:
- Knowledge of the regulatory processes and pathways for approval to market medical devices for use with patients.
- Knowledge to identify relevant regulatory requirements and documentation in the design, development, testing, manufacture and marketing of medical devices for compliance with regulatory agency polices, regulations and standards.
- Additional credentialling that builds on degrees in engineering, science and technology programs for students entering medical device industry, governmental agencies, or pursuing entrepreneurship opportunities.
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Certificate in Regulatory Affairs for Medical Devices
Purpose is to prepare individuals to pursue careers in the regulatory affairs for medical devices including radiological devices. Individuals working in regulatory affairs manage the regulatory process for companies innovating and developing cutting edge medical devices in the US as well as in international markets. The 12-credit, 4 course program provides understanding and knowledge of requirements and processes related to medical device design and development, good manufacturing and quality management, testing requirements and documentation needed for medical device manufacturers to meet regulatory requirements. The advanced knowledge gained will provide graduates the tools and understanding of the regulatory processes needed to help facilitate the commercialization and marketing of safe and effective medical devices by manufacturers and to pursue career as a regulatory professional. |
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