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
- 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.
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.
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.
Note: Six credit units may be counted toward the Clinical Trials: Medical Device and Drug Development Certificate Program.
All requirements must be completed within five (5) years after the student enrolls in his/her first course.
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Stay Informed About
Medical Product Development
Program Benefits
- 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.
- 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.
Graduates from UC Irvine Extension’s Medical Product Development program are eligible to transfer credits to Keck Graduate Institute’s Masters of Bioscience program; Northeastern University’s Master of Regulatory Affairs program; and University of Nebraska – Lincoln’s Master’s in Engineering Management.
Advisory Committee
- Dan Modi, Director, Quality & Regulatory Certification, 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
- Kikoo Tejwani, Corporate Vice President Quality/Regulatory Compliance, B. Braun Medical Inc.
- Bruce Sargeant, COO, Source Scientific
- Carl Wyrwa, Director of Quality, Beckman Coulter, Inc.
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