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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 in the US. Source: Economic Modeling Specialists Intl.

20,552
Annual Job Openings
(2019)
8%
Projected Growth
(2019-2029)
$88k
Median Salary
(Highly experienced workers can earn up to $144k)
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 Medical Devices (3.00 Units)
EECS X445.2
to be scheduled Online   to be scheduled
BME X408
Medical Device Life-Cycle Management (3.00 Units)
BME X408
  Online   to be scheduled
MGMT X442.6
Medical Device Quality Systems (3.00 Units)
MGMT X442.6
to be scheduled   Online  

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    
Quality and Compliance
EECS X445.22
Medical Product Manufacturing (3.00 Units)
EECS X445.22
    Online  
BME X407
Process Validation for Medical Device Development (3.00 Units)
BME X407
    to be scheduled  
BME X406
Medical Device Risk Management (3.00 Units)
BME X406
to be scheduled      
BIO SCI X450
Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
to be scheduled   Online  
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    

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

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Academic Calendar

Event Spring 2020 Summer 2020 Fall 2020 Winter 2021
Registration Begins Jan 24 Apr 24 Jul 17 Oct 23
Courses Begin* (week of) Mar 30 Jun 22 Sep 21 Jan 4
Courses End* (week of) Jun 8 Sep 7 Dec 14 Mar 15
Parking Permits Expire Jun 30 Sep 30 Dec 31 Mar 31
Administrative Holidays Mar 27, May 25 Jul 3, Sep 7 Nov 11, Nov 26-27, Dec 24-25, Dec 31 Jan 1, Jan 18, Feb 15

*Actual dates may vary by program.

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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.

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

Frequently Asked Questions

  • How much does the program cost?
  • Fees for each course vary from $525 - $725 based on unit value. There is also a one-time candidacy declaration fee of $125, to be paid after your second class. Therefore, the entire program costs $4,425. Note that you pay for each class as you enroll, as opposed to the entire tuition sum at once. Please keep in mind that this cost does not include textbooks, which some of our instructors do require. Textbook information for specific courses can be found on our website on the enrollment page. Students may purchase textbooks from the vendor of their choice. Prices are subject to change without notice.
  • How long will it take me to complete the entire program?
  • It depends on how many classes you can take at once. A certificate is awarded upon completion of 15 total units, the 9 required courses and minimum of 6 elective credit units. On average you can complete the program in 9-15 months. Most students who work full time take one or two classes per quarter, depending on their work schedules and other obligations. You can take as many courses as you wish simultaneously, but we strongly recommend starting with one or two to ensure you have the necessary time to devote to the course(s).
  • Do I have to apply and be accepted before I start?
  • No. This is an open-enrollment program, and you will not have to provide transcripts or prove prerequisites before you begin.
  • If I am interested in taking courses from other Life Sciences Certificate Programs can these programs share electives?
  • Yes, you can share up to six units or two electives courses between the Clinical Trials: Medical Device and Drug Development Certificate Program and the Regulatory Affairs and Compliance Certificate Program.
  • Where can I find the course schedule? Do I have to take the classes in order?
  • The course schedule can be found here. You may take the classes in any order that you like. We recommend, starting with the required courses as they build the foundation of the program and then moving onto the elective courses.
  • Can I complete the entire program online?
  • Yes, this is a fully online program.
  • I've never taken an online class. How does it work? Is it self-paced?
  • No, the classes are not self-paced. Our online classes take place in an asynchronous online environment, meaning there will not be a day of the week or time of day that you will need to be online. You can log in when you have time to do so. However, the courses are structured week-to-week, from Monday to Sunday, and you are expected to log in multiple times during the week to keep up with class discussions and assignments. Some instructors may hold optional synchronous sessions which happen in real time. These sessions will be recorded and posted in the course for all students to access.
  • I am an international student / I am located overseas – am I able to enroll?
  • Yes. As an open-enrollment program, international students are welcome in the program. Please note that if English is not your native language, enrollment in this program assumes that you have a working proficiency in English to allow you to engage in high-level academic discourse without any additional language coaching. If you are interested in taking the program fully online, you may enroll in courses via the Continuing Education website at your convenience and on a quarter by quarter basis. You are not required to have a student visa while taking online courses from your home county.

    If you wish to apply for an F-1 student visa to study in person at UC Irvine Division of Continuing Education (DCE), you must formally apply to UC Irvine DCE's International Programs and request an I-20. Please keep in mind that not all evening certificate programs are available to F-1 student visa holders based on the availability of classes that meet on campus. We cannot issue an I-20 for fully online programs. Please visit International Programs or email uciesl@uci.edu for more information.
  • Do you offer job placement at the end of the program?
  • No. While UCI DCE does not offer placement services, our certificate certainly puts you in a good position to find employment. Additionally, the networking to be done in the class can also be invaluable. Our advisors, instructors, and a good number of our students, are current professionals in the industry, and are an excellent resource for hiring trends and opportunities.
  • Is UC Irvine Division of Continuing Education an accredited institution?
  • Yes. We are affiliated with the University of California system of schools, and are accredited through WASC. DCE programs are all approved by the respective school within UCI. For more information, please visit UCI Accreditation.
  • What is the “declaration of candidacy”? When do I have to complete it?
  • The declaration of candidacy can be thought of as declaring your major for the certificate program. This lets our student services know that you intend to complete the entire program, and puts you on track for the certificate when you have completed all requirements. We strongly recommend that you complete the declaration of candidacy and pay the applicable fee before enrolling into your third class.
  • Are there scholarships or financial aid available for this program?
  • Since UCI DCE is the continuing education unit of the university, we do not offer/accept any federal financial aid or scholarships. If you take courses through us, you may apply directly to private lenders like Wells Fargo for funding. It is recommended that you begin the loan application process early as UCI DCE does not enroll students in courses until payment is received, and applying for a loan does not reserve a space in the course. For more information, please visit Student Loan Programs. If you have any questions regarding student loans, please contact Student Services at 949-824-5414. For more financial information, please go to Financial Information.
  • I can't find the answer to my question.
  • If you have any additional questions, please feel free to contact Kadie Heck at kheck1@uci.edu or (949) 824-7648.

Advisory Committee

  • Bill Carpou, 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.