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Medical Device Development

Overview

Emerging disruptive 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 research, conceptualization, development and manufacturing of medical devices. The curriculum addresses the design, development, and manufacturing processes including quality, safety, regulatory compliance, commercial and financial strategies, and post market surveillance.


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

Who Should Enroll

  • Regulatory professionals, such as those in regulatory affairs or quality assurance
  • Research, development and engineering professionals involved in biomedical product design, development, validation, and manufacturing
  • Manufacturing professionals
  • Clinical managers and other healthcare professionals
  • Field service engineers, commercial marketing and sales professionals
  • Life science managers, such as research scientists and product managers

Career Insight

Occupational summary for biomedical engineers.

22,546
Jobs
(2019)
6.4%
Projected Growth
(2019-2029)
$68k-$113k
Annual Salary
(25th-75th Percentile)
Life Science Industry in Orange County

Program Benefits

  • Gain the knowledge needed to design, create and manufacture medical devices
  • 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 design and manufacture medical products by avoiding common quality and regulatory pitfalls
  • Earn professional development credits to maintain your RAC credential with RAPS – Regulatory Affairs Professional Society
  • Learn from seasoned instructors with practical industry experience

Course Schedule

Required Courses

TitleWinterSpringSummerFall
EECS X445.2
Regulatory Requirements for Med Devices (3.00 Units)
EECS X445.2
Online Online   to be scheduled
BME X408
Medical Product Life-Cycle Management (3.00 Units)
BME X408
  Online   to be scheduled
MGMT X442.6
Medical Product Quality Systems (3.00 Units)
MGMT X442.6
Online   to be scheduled  

Elective Courses

TitleWinterSpringSummerFall
Regulatory Affairs
MGMT X445
Medical Device Marketing (3.00 Units)
MGMT X445
  Online   to be scheduled
MED X413.4
Application of Good Clinical Practices (3.00 Units)
MED X413.4
  Online    
BME X414
Biomedical Business and Legal Management Essentials (3.00 Units)
BME X414
Online      
Quality and Compliance
EECS X445.22
Medical Product Manufacturing (3.00 Units)
EECS X445.22
    to be scheduled  
BME X407
Process Validation for Medical Device Development (3.00 Units)
BME X407
       
BME X406
Medical Device Risk Management (3.00 Units)
BME X406
Online      
BIO SCI X450
Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
Online   to be scheduled  
MED X413.41
Good Laboratory Practices (1.50 Units)
MED X413.41
      to be scheduled
Engineering and Science
BME X405
Applied Anatomy and Physiology for Clinical Studies (4.00 Units)
BME X405
      to be scheduled
EECS X445.23
Medical Device Design, Evaluation and Commercialization (3.00 Units)
EECS X445.23
  Online    
Also of Interest
MED X413.44
Clinical Trials Internship (3.00 Units)
MED X413.44
       

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 with a non-refundable $125 application fee. Students are encouraged to declare candidacy as soon as possible, but no later than after the third course in the program. To receive the digital 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)

Transfer Credits

Graduates from UCI Division of Continuing Education's Medical Device Development program are eligible to transfer credits to:

Note: Any student wishing to transfer credits must obtain a “B” or better in each course.

Medical Device Development Information Session
View Webinar

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.