From tongue depressors to Fitbits
The program gives you a foundation to understand the development and commercialization of safe and effective medical devices and in vitro diagnostic devices (IVDs). Students learn to research, design, develop, regulate, test, and market new devices and biologics. Experienced and aspiring medical device professionals will gain insight into the technological, ethical, regulatory, and business aspects of the highly regulated medical device industry.
Medical Device certificate program objectives:
- Use nine elements of design control for medical devices
- Navigate post-market regulatory requirements for devices
- Market medical devices
- Decode regulatory compliance, including medical device quality system regulations and ISO 13485
- Explore the product development life cycle for medical devices
- Set up and implement medical device verification and validation programs
Cost: $7,000 | International Tuition Cost
Required Credits: Total Required: 17 units/7 courses. Take 5 core courses (12.5 units) and 2–3 elective credit courses (4.5 units). End with certificate of completion review.
Duration: A full-time student can complete the certificate in 12 months.
Please review the course descriptions to ensure that you have taken necessary prerequisites or meet the requirements through job experience or previous education.
Statistics Knowledge: You will need an understanding of statistics for this program. UCSC Extension offers Statistics.
Recommended Course Sequence
Please follow this sequence. Students new to the industry should begin with Quality Systems for Medical Devices FDA QSR and ISO 13485 (formerly Medical Device Quality Systems) followed by Regulation of Medical Devices and Diagnostics. For those with experience in this field, courses can be taken in any order provided the prerequisites are met.
An introductory course to medical devices regulation or Medical Devices: Regulatory Strategies and Marketing Pathways taken within the last five years fulfills the requirement of Regulation of Medical Devices and Diagnostics. Also you may take one elective outside the certificate curriculum, if you receive prior approval from the Academic Services Department.
Dual Certification & Shared Credit
Learn more for Less: You can complete two bioscience certificate programs at UCSC Extension simultaneously or in sequence with fewer units than if the programs were taken individually. Students pursing two certificates need to:
- Complete the total number of units indicated in the table below.
- Complete all required courses for both programs.
- Count each unit only once.
- Select some electives that are common to both programs.
|Biotechnology||Clinical Trials||Medical Devices||Regulatory Affairs||Bioinformatics|
|Biotechnology||19 units||32 units||31 units||32 units||30 units|
|Clinical Trials||32 units||19 units||31 units||32 units||X|
|Medical Devices||31 units||31 units||17 units||31 units||X|
|Regulatory Affairs||32 units||32 units||31 units||19 units||X|
|Bioinformatics||30 units||X||X||X||16 units|
Certificate Program Chair
KIRAN GULATI, RAB-LA, M.B.A., is a management consultant with more than 25 years' experience in quality systems and process improvement for the medical device and biotech sectors. She has held positions at Genentech and McGhan Medical (formerly Collagen Corporation), where she managed the auditing and quality system training functions and has extensive experience designing and training for companies in domestic and international settings. Since 2001, she has helped medical device startups and established companies achieve successful results during ISO 13485, CE Mark assessments, and FDA audits. Gulati has served as chair of RAPS San Francisco Bay Area chapter and is currently on the RAPS North American Advisory Board. She has been a speaker at conferences sponsored by the Institute of Validation Technology (IVT) and the ASQ Silicon Valley Division. She has taught for UCSC Extension since 2006 and serves on the advisory boards for the UCSC Extension Medical Devices and Regulatory Affairs certificate programs.
Certificate Program Advisory Committee
MEREDITH BROWN-TUTTLE, BA, RAC, FRAPS
Regulatory Affairs Consultant
KIRAN GULATI, RAB-LA, M.B.A.,
Principal Medical Device Consultant/Exemplar Medical Device Lead Auditor
Kiran Gulati & Associates
Program Chair, Regulatory Affairs, UCSC Silicon Valley Extension
Program Chair, Medical Devices, UCSC Silicon Valley Extension
NANCY E. ISAAC, JD, MPH
Regulatory Counsel and VP Quality
NIRANJAN MAHARAJH, MS, BS
Carl Zeiss Meditec, Inc.