Emerging technologies, ever-changing regulations, and increased competition create many challenges for the medical product industry. UC Irvine Extension's program, developed with government and industry advisors, fulfills a recognized need for comprehensive professional learning in the successful design, development and delivery of medical devices, pharmaceuticals, and other biomedical products. The curriculum addresses the breadth of the development process, including a thorough understanding of compliance, engineering for improved performance, how to mitigate commercial and financial risks, and building marketing success.
Who Should Enroll
- Regulatory professionals, such as those in regulatory affairs or quality assurance
- Engineers, such as those involved in biomedical product design and development
- Manufacturing professionals
- Clinical managers and other healthcare professionals
- Life science managers, such as research scientists and product managers
A certificate is awarded upon completion of 15 credit units (9 required and 6 elective credit units), with a grade point average of "B" or better.
Note: Six credit units may be counted toward the Clinical Trials: Medical Device and Drug Development Certificate Program.
To become an official candidate in the program, students pursuing the certificate must submit a Declaration of Candidacy. To receive the certificate after completing all program requirements, students must submit a Request for Certificate. All requirements must be completed within five (5) years after the student enrolls in his/her first course. Students not pursuing the certificate program are welcome to take as many individual courses as they wish.
On-site Training Available
Through Corporate Training, we can deliver this program or customize one that fits
your organization's specific needs. Visit Corporate Training
or call (949) 824-1847 for information.
Stay Informed About
Medical Product Development
Regulatory Affairs: An Opportunity to Excel in Biotechnology
- Gain the knowledge needed to design and create medical devices and pharmaceuticals
- Acquire an understanding of the medical device product development process and knowledge needed to manage medical device intellectual property rights
- Learn how to implement successful medical device design and manufacturing by avoiding common quality and regulatory pitfalls
- UC Irvine Extension is a RAPS registered provider for professional development
- Earn credits to qualify for RAC recertification
- Learn from instructors seasoned in practical industry experience who share their
Graduates from UC Irvine Extension's Medical Product Development program are eligible to transfer credits to
University of Nebraska-Lincoln’s Masters in Engineering Management and University of Wisconsin-Platteville Masters of Science in Engineering.
- Matthew Jenusaitis, President and CEO, OCTANe
- Dan Modi, Director, Quality & Regulatory Certification, Alcon Research, Ltd.
- Albert Rego, Scientific Consultant to the Life Science Industry
- Bruce Sargeant, COO, Source Scientific
- Sumit Sen, Chemist (Technology-Based Expert), U.S. Food and Drug Administration
- Del Stagg, Ph.D., founder, Orange County Regulatory Affairs (OCRA) and North Carolina Regulatory Affairs Forum (NCRAF)
- Eric Sun, CEO, QS Labs
- Carl Wyrwa, Director of Quality, Beckman Coulter, Inc.
- Jeff Yuen, President and CEO, Jeff Yuen & Associates, Inc.