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Dec 06, 2025
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2025-2026 University Catalog
Regulatory Affairs and Regulatory Science for Medical Devices, Post-Baccalaureate Certificate
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About the Program
Students enrolled in the certificate program will participate in a sequence of courses designed to educate participants on practical regulatory affairs at both the initial approval and later compliance stages. Students gain valuable in-depth knowledge of regulatory requirements as well as guided practice with effective regulatory document submissions. This advanced education in quality and regulatory compliance will prepare students for rapid integration into regulatory affairs teams in critical areas of the industry. Program Requirements
9 Credits RequiredRequired Courses (6-9 credits)
Choose two of the three regulatory courses listed below. Students may take the third course and no selective course if they would like to take all three. An average grade of B or higher in the two core courses and an average of 3.0 or higher overall are required. Selectives (0-3 credits)
Choose one (if all three courses were not taken above). Program Learning Outcomes
Students will: - Demonstrate knowledge of regulatory considerations and perspectives in the course of medical device development.
- Identify and effectively communicate important regulatory information in written and oral form.
- Discuss emerging or current key areas and priorities in Regulatory Science.
- Explain the current US FDA regulatory system and submission pathways for medical devices.
- Demonstrate practical understanding of ethics and compliance issues related to medical device development and manufacturing.
Graduate Programs Disclaimer
- The student is ultimately responsible for knowing and completing all degree requirements. Students should consult with their advisor/department for more information.
- Not all graduate programs may be actively recruiting students and course modality availability may vary.
- Please refer to the Explore Graduate Programs website for a list of currently available graduate programs.
- Transfer credit policy: Credits earned for graduate study at other universities (both domestic and international) may be applied toward an advanced degree. Only credit hours associated with graduate courses for which grades of B- or better were obtained will be eligible for transfer. Any additional conditions under which credit transfers may be made are determined by the various departments.
- Comparative information about Purdue University and other U.S. educational institutions is also available through the College Navigator tool, provided by the National Center for Education Statistics, and through the U.S. Department of Education College Scorecard.
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