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 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 Clinical Trials: Medical Device and Drug Development Certificate Program. An Application for Candidacy must be submitted before completion of the third course in the program.

All requirements must be completed within five (5) years after the student enrolls in his/her first course.

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.

English Proficiency Requirement
All certificate programs at UC Irvine Extension (classroom and online formats) require professional-level English language proficiency in listening and note-taking, reading comprehension and vocabulary, written expression, and oral presentation. If you would like to refine your English language proficiency prior to beginning one of our programs, please see our English Language Programs.

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.
• 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.

Transfer Credits

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.

Advisory Committee

• 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
• Eric Sun, CEO, QS Labs
• Kikoo Tejwani, Corporate Vice President Quality/Regulatory Compliance, B. Braun Medical Inc.
• Carl Wyrwa, Director of Quality, Beckman Coulter, Inc.
• Jeff Yuen, President & CEO, Jeff Yuen & Associates, Inc.