Introducing our recently refocused Medical Device Quality Design certificate focused on advancements in the healthcare industry. We now have two tracks for you to tailor your curriculum interest.
From tongue depressors to Fitbits
Digital health, smart wearable devices, medical device software and in-vitro diagnostics are just a few of the latest strides in the highly regulated healthcare industry.
The Medical Device Quality and Design certificate program prepares students by focusing on the latest technological and regulatory advancements in the field.
You'll study the front end of medical device design and development used to verify that design inputs meet design outputs, including:
- User needs,
- Risk management,
- Human factors, and
You will be exposed to the fundamentals and underlying concepts on how to demonstrate compliance with key regulations. (See learning outcomes below) Global harmonization quality compliance initiatives will also be addressed.
Two tracks of study
- Medical Device Quality Design
- Medical Device Software Quality
Based on your interests, you can choose the track that best suits your interest.
Medical Device Quality and Design learning outcomes
- Interpret and develop documentation that complies with
- U.S. FDA quality system requirements (21 CFR 820)
- European Medical Device Regulations (EU MDRS / IVDRS), ISO 13485
- Risk management (ISO 14971).
- Write a risk management plan and risk management report.
- Apply risk management principles to develop verification and validation plans for software and manufacturing processes.
- Develop a human factors usability plan.
- Interpret FDA guidelines and regulations and develop quality test plans for digital health and medical device software.
- Explain and apply risk management principles defined in ISO 14971 throughout the design and development lifecycle, such as product risk, software risk, and cybersecurity risk.
Cost: Track 1: $4,845 • Track 2: $5,605 | International Tuition Cost
Required Credits: Total Required: 14 units (6 courses). Select one track of study.
Duration: A full-time student can complete the certificate in 12 months.
Certificate Inquiry Form
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.
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.
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.
You can enroll in a certificate program any time during your studies.
Once you create your student account, you can enroll in a certificate program. Although you can enroll in a program at any time, the benefit of enrolling early is that it locks in your certificate requirements. This means that even if program requirements change, the requirements to complete your certificate will remain the same for you.
- You must enroll in the certificate program before enrolling in the Certificate Completion Review.
You have a total of five years to complete all necessary courses in a certificate program.
All the necessary units in a certificate must be completed within a five-year window. The clock begins on the first day of your first course in the certificate program. For example, if you started a course on Sept. 5, 2017, you would have to complete all of the required units in this certificate by Sept. 4, 2022.
- Enrolling in a certificate program does not trigger the beginning of the five-year window. It begins the first day of the first course that applies to a certificate program.
- The Certificate Completion Review process does not have to occur within the five-year timeframe.
Please note that only letter grades of C- or higher may be applied to a certificate, and in some programs, students may have more stringent requirements. Students in most employer- and government-sponsored payment programs, such as workforce development, as well as international students on F-1 visas, need to maintain a B average to meet their requirements. Personal Financial Planning students have additional grade requirements for individual courses to attain a certificate.
See Grading and Credits Policy for further information.