From discovery to market
9 - 12 months
5736861
These Courses are Perfect For
- Technical professionals seeking proficiency in regulated medical device development
- Regulatory and quality practitioners pursuing structured, compliance-focused education
- Professionals in need of flexible, credentialed learning aligned with industry standards
Program review underway
As we evolve our programs to reflect today’s technology landscape, the certificate in Medical Device Quality and Design is under review and is not currently open for new enrollment. If you are enrolled in this certificate and are finishing up your courses, please reach out to us at extension@ucsc.edu. We will help you plan your journey.
After reviewing the current market conditions and engaging with industry, we are now offering new short programs, that are flexible paths to get the skills you need fast. During this time, our certificate programs continue to be under review and we are committed to assisting all enrolled students to finish the certificate programs. To learn more, visit our Short Programs page.
Courses are open to everyone
You are invited to enroll in individual courses to build your knowledge and develop new skills.
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.
In the Medical Device Quality and Design certificate program students focus on technological and regulatory advancements in the field. They learn the fundamentals and underlying concepts of regulatory compliance, as well as global harmonization quality compliance initiatives.
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
- Methodologies.
What you will learn
- 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
Courses
Program Requirements
Total: 6–8 courses (14 quarter units)
End with Certificate of Completion review.
1. Core Course(s): Medical Device Quality & Design
MEDD.X407
$815
You may enroll in this offering at any time.
Feb. 9 - Mar. 23, Tue, 6:00pm - 9:30pm
- Live-Online Attend via Zoom at scheduled times.
MEDD.X407.(20)
Schedule
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Tue, 02-09-2027 | 6:00pm | 9:30pm | Live-Online | REMOTE |
| Tue, 02-16-2027 | 6:00pm | 9:30pm | Live-Online | REMOTE |
| Tue, 02-23-2027 | 6:00pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-02-2027 | 6:00pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-09-2027 | 6:00pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-16-2027 | 6:00pm | 9:30pm | Live-Online | REMOTE |
| Tue, 03-23-2027 | 6:00pm | 9:30pm | Live-Online | REMOTE |
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Winter
MEDD.X410
$795
You may enroll in this offering at any time.
Jan. 23 - Mar. 13, Sat, 9:00am - 12:00pm
- Live-Online Attend via Zoom at scheduled times.
MEDD.X410.(15)
Schedule
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Sat, 01-23-2027 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 01-30-2027 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 02-06-2027 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 02-20-2027 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 02-27-2027 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 03-06-2027 | 9:00am | 12:00pm | Live-Online | REMOTE |
| Sat, 03-13-2027 | 9:00am | 12:00pm | Live-Online | REMOTE |
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
No meeting on February 13, 2027. To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Required Textbook:
Introduction to Medical Software, Xenophon Papademetris, Ayesha N. Quraishi and Gregory P. Licholai, Cambridge University Press, 2022. ISBN: 9781009090148
|| Prerequisites:
Prerequisites / Skills Needed
Winter
Currently no classes scheduled. Would you like to be notified when a class is available?
Fall
Currently no classes scheduled. Would you like to be notified when a class is available?
Fall
Currently no classes scheduled. Would you like to be notified when a class is available?
Summer
Currently no classes scheduled. Would you like to be notified when a class is available?
2. Completion Review:
O-CE0403
$95
You may enroll in this offering at any time.
Schedule
Please enroll in the Medical Device Quality and Design Certificate Completion Fee only once all of the certificate requirements have been met and your final grades are posted.
Recommended course sequence
Students new to the industry should begin with Quality Management Systems for Medical Devices: ISO 13485 and FDA QMSR. For those with experience in this field, courses can be taken in any order provided the prerequisites are met.
Requisite knowledge
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.
Grade requirements
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.
See Grading and Credits Policy for further information.
Instructors
Program Chair
Kiran Gulati
Principal Medical Device Consultant / Program Chair
KIRAN GULATI is an instructor and program chair of the Regulatory Affairs and Medical Device Quality & Design certificate programs at UCSC Silicon Valley Extension. She is also the principal medical device consultant at Kiran Gulati & Associates with over 30 years of experience working with medical devices. She is an Exemplar-certified lead auditor and provides companies with guidance with global regulatory compliance strategies. Gulati has a proven track record assisting medical device companies with preparing for MDSAP, ISO 13485, EU MDR, and QMS audits with regulatory agencies. She has worked at Genentech and McGhan Medical (formerly Collagen Corp.), where she managed the corporate audit functions and led quality management system integration efforts. She has extensive experience in designing corporate training and has been a speaker at conferences such as the RAPS Regulatory Convergence, the Institute of Validation Technology, and the ASQ Silicon Valley Division. At UCSC Silicon Valley she teaches Quality Systems for Medical Devices: ISO 13485 and FDA Requirements and Conducting Value-Added Audits. Gulati enjoys volunteering with the local RAPS chapter and was chair of the San Francisco Bay Area RAPS Chapter (2011-2014). In 2013 and 2014, she planned meetings and collaborated with representatives from the Center for Devices and Radiological Health to help educate industry on the Case for Quality Initiative. As a volunteer for RAPS, she has also served on the Convergence Planning Committee, on the Nominating Committee for the RAPS Board of Directors, and recently served as a section reviewer for RAP’s new publication, "Fundamentals of Medical Device Regulations: A Global Perspective." Gulati enjoys teaching and mentoring her students and professionals who are aspiring to work in the medical device/biotech industries. In August of 2020, Kiran was awarded the RAPS Community Leadership Award for her contributions to the regulatory profession.
Certificate Program Advisory Committee
TONY DELIZZA, MS
Principal, First Light, LLC
KIRAN GULATI, RAB-LA, M.B.A.
Management Consultant
Program Chair | Instructor Medical Device Design and Management Certificate Program
SURINA GULATI, MBEE
Quality Systems Engineering Lead | iRhythm Technologies Inc
Instructor, Medical Device Quality and Design Program, UCSC Silicon Valley Extension
RITAM PRIYA, MBA
Medical Devices, Head of Regulatory Affairs, Meta
DINESH PUPPALA, MS
Regulatory Affairs Manager, Google LLC
JAY VAISHNAV, Ph.D
Director Regulatory Affairs, Canon Medical Informatics
Instructor, Regulatory Affairs Certificate Program, UCSC Silicon Valley Extension
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