Overview
 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 Attend
This program benefits a wide variety of Life Science professionals in biomedical, biotech, and clinical arenas who need either specific knowledge of the medical product development process or a broad understanding of the products they use or market.
- Life science managers, such as Research Scientists and Product Managers
- Regulatory professionals, such as those in Regulatory Affairs or Quality Assurance
- Non-technical managers, such as Finance and Administration
- Engineers, such as those involved in biomedical product design and development
- Manufacturing professionals
- Clinical managers and other healthcare professionals
Certificate Candidacy
Degreed professionals OR those with an associate degree; OR equivalent work experience with consent of the program director. An Application for Candidacy must be submitted before completion of the third course in the program.
Certificate Requirements
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 Clincial Trials: Medical Device and Drug Development Certificate Program.
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Program Benefits
- Combine courses, schedules and sequences to fit your business needs.
- Earn a certificate in as little as 9 months.
- Enhance your marketability with a practical credential.
- Choose from face-to-face and online options.
- Earn credits to qualify for RAC recertification. UC Irvine Extension is a RAPS registered provider for professional development
- Learn from instructors seasoned in practical industry experience who share their knowledge effectively.
- MCLE credit available on select courses.
Transfer Credit
As a "next step" on your educational pathway, UC Irvine Extension has an articulation agreement with Keck Graduate Institute (KGI) of Applied Life Sciences in which they will accept coursework from this certificate program as credit towards a Fully Employed Master of Bioscience Degree Program.
Advisory Committee
- Dan Modi, Associate Director, Product Certification and Regulatory Affairs, Alcon Research, Ltd.
- Vytas Pazemenas, President, Medical Device Technology, Aubrey Group
- Albert Rego, Scientific Consultant to the Life Science Industry
- Sumit Sen, Chemist (Technology-Based Expert), U.S. Food and Drug Administration
- Eric Sun, CEO, QS LABS
- Carl Wyrwa, Manager, Software Quality Assurance, Beckman Coulter, Inc
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