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Medical Device Development


Emerging disruptive technologies, ever-changing regulations, and increased competition create many challenges for the medical device industry. This program provides comprehensive professional training in the successful research, conceptualization, development, and manufacturing of medical devices. Evaluated and developed in collaboration with governmental and industry advisors, this program meets the highest professional development standards for the medical device industry.

The updated curriculum addresses current industry trends and best practices in medical device design, development, and manufacturing. Coursework covers quality, safety, regulatory compliance, commercial and financial strategies, and post-market surveillance. Updated EU-MDR requirements are now included in the Regulatory Requirements for the Medical Devices course.

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
OCRA | Orange County Regulatory Affairs
OCRA members save 10% on tuition.
SDRAN | San Diego Regulatory Affairs Network
SDRAN members save 10% on tuition.

Program Benefits

  • Gain the knowledge needed to design, create and manufacture medical devices
  • Acquire an understanding of the medical device product development process and expertise required 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

EECS X445.2
Regulatory Requirements for Medical Devices (3.00 Units)
EECS X445.2
  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
Online   to be scheduled  

Elective Courses

Medical Device Development
Medical Device Marketing (3.00 Units)
  Online   to be scheduled
EECS X445.22
Medical Device Manufacturing (3.00 Units)
EECS X445.22
    to be scheduled  
BME X406
Medical Device Risk Management (3.00 Units)
BME X406

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

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Academic Calendar

Event Winter 2024 Spring 2024 Summer 2024 Fall 2024
Registration Begins (after 2pm PT) Oct 19 Jan 18 Apr 18 Jul 11
Courses Begin* (week of) Jan 8 Apr 1 Jun 24 Sep 23
Courses End* (week of) Mar 18 Jun 10 Sep 9 Dec 9
Administrative Holidays Jan 15, Feb 19 Mar 29, May 27 Jun 19, Jul 4, Sep 2 Nov 11, Nov 28-29, Dec 24-25, Dec 31, Jan 1

*Actual dates may vary by program.

Learn How To Earn Your Certificate

Earn a Certificate

Apply to become a candidate for the program: A Declaration of Candidacy is required to establish candidacy in this program. Complete the application and pay the application and candidacy fee of $125 (non-refundable). Learn more about the benefits of becoming a candidate. Candidacy is not required to enroll into individual course in a program.

A candidate in the program is awarded a certificate upon the successful completion of 9 required units and 6 elective credit units totaling 15 units, each with a letter grade of “C” or better. All requirements must be completed within five (5) years after the student enrolls in their first course. To receive the Certified Digital Certificate after the completing all the program requirements, students must submit the Request for Certificate to initiate the certificate audit process. Students not pursuing the certificate are welcome to take as many individual courses as they wish.

Note: Six credit units may be counted toward the Clinical Trials: Medical Device and Drug Development Certificate Program when courses are shared.

Advisory Committee

  • Matthew Jenusaitis, Chief of Staff, UC San Diego, Health System
  • Albert Rego, Scientific Consultant to the Life Science Industry
  • Del Stagg, Ph.D., Regulatory Consultant, Founder of the Orange County Regulatory Affairs Society (OCRA)

Career Advancement Network (CAN)

We are proud to provide our certificate students and alumni with newly enhanced career services that include one-on-one coaching, technology tools, webinars and workshops, networking events, mentorship/internship opportunities, and a rich collection of free online career resources. Learn more.

Frequently Asked Questions

  • How much does the program cost?
  • Fees for each course vary from $525-$735 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 $4,400. 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 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 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

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.

Medical Device Development Information Session
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