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Medical Product Development

Overview

Emerging technologies, ever-changing regulations, and increased competition create many challenges for the medical product industry. UCI Division of Continuing Education'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.


Members save 10% on one
UCI DCE course per quarter.

Members save 10% on one
UCI DCE course per quarter.

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

Career Insight

Occupational summary for biomedical engineers in the United States.

21,349
Jobs
(2016)
21.10%
Projected Growth
(2017-2027)
$66k-$108k
Annual Salary
(25th-75th Percentile)

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
  • UCI Division of Continuing Education is a Regulatory Affairs Professional Society (RAPS) professional development provider
  • Earn credits to qualify for RAC recertification
  • Learn from instructors seasoned in practical industry experience who share their knowledge effectively

Course Schedule

Required Courses

TitleWinterSpringSummerFall
BME X408
Medical Product Life-Cycle Management (3 units)
BME X408
  to be scheduled   Online
EECS X445.2
Regulatory Requirements for Medical Devices (3 units)
EECS X445.2
to be scheduled to be scheduled   Online
EECS X445.2 OR EECS X445.26

EECS X445.2 OR EECS X445.26
EECS X445.26
Regulatory Requirements for Pharmaceutical Products (3 units)
EECS X445.26
  to be scheduled Online Online
MGMT X442.6
Medical Product Quality Systems (3 units)
MGMT X442.6
to be scheduled   Online  

Elective Courses

TitleWinterSpringSummerFall
Regulatory Affairs
MGMT X445
Medical Product Marketing (3 units)
MGMT X445
  to be scheduled   Online
MED X413.4
Application of Good Clinical Practices (3 units)
MED X413.4
  to be scheduled Online  
BME X414
Biomedical Business and Legal Management Essentials (3 units)
BME X414
to be scheduled   Online  
Quality and Compliance
EECS X445.22
Medical Product Manufacturing (3 units)
EECS X445.22
    Online  
BME X407
Process Validation for Medical Product Development (3 units)
BME X407
       
BME X406
Medical Device Risk Management (3 units)
BME X406
to be scheduled      
BIO SCI X450
Fundamentals of Clinical Trials (3 units)
BIO SCI X450
to be scheduled   Online  
MED X413.41
Good Laboratory Practices (1.5 units)
MED X413.41
      Online
Engineering and Science
BME X405
Applied Anatomy and Physiology for Clinical Studies (4 units)
BME X405
      Online
EECS X445.23
Medical Device Design and Evaluation (3 units)
EECS X445.23
  to be scheduled    

Course schedules are subject to change. Individual courses may be taken without enrolling in the full certificate.

Receive Customized Training for your Employees

Certificate Eligibility and Requirements

Learn How To Earn Your Certificate A certificate is awarded upon completion of 15 credit units (9 required and 6 elective credit units), with a grade of “C” or better in each course. Note: Six credit units may be counted toward the Clinical Trials: Medical Device and Drug Development Certificate Program when courses are shared.

To become an official candidate in the program, students pursuing the certificate must submit a Declaration of Candidacy. Students are encouraged to declare candidacy as soon as possible, but no later than after the third course in the program. 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 a certificate are welcome to take as many individual courses as they wish.

Breaking into the Business of Regulatory Affairs & Biotechnology (4/11/18)

RAPS Professional Development provider
UCI Division of Continuing Education is a Regulatory Affairs Professionals Society (RAPS) Professional Development provider. UCI Division of Continuing Education is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs UCI Division of Continuing Education has agreed to follow RAPS’ established operational and educational criteria.

Advisory Committee

  • Bill Carpov, President and CEO, OCTANe
  • Todd Cushman, President & CEO, Bioness
  • Matthew Jenusaitis, Chief of Staff, UC San Diego, Health System
  • Dan Modi, Director, Quality & Regulatory Certification, Alcon Research, Ltd.
  • Albert Rego, Scientific Consultant to the Life Science Industry
  • Bruce Sargeant, Founder, CEO, Fusion Biotec, Inc.
  • Sumit Sen, Chemist (Technology-Based Expert), U.S. Food and Drug Administration
  • Travis Smith, Managing Director, Square-1 Engineering; President, DeviceAlliance
  • Del Stagg, Ph.D., Regulatory Consultant, Founder of the Orange County Regulatory Affairs Society (OCRA)
  • Eric Sun, CEO, QS Labs
  • John Via, D. Eng., P.E., Consultant, Pharmaceutical & Medical Device Manufacturing
  • Carl Wyrwa, President, CW Software Solutions, Inc.
  • Jeff Yuen, President and CEO, Jeff Yuen & Associates, Inc.

On-site Training Available

Our Corporate Training specialists 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 UCI Division of Continuing Education (classroom and online formats) require professional-level English language proficiency in listening and note-taking, reading comprehension and vocabulary, written expression, and oral presentation.