Medical Devices
Certificate Program

Medical Devices

From discovery to market
Enroll in Certificate Program View Individual Courses
Shilpa Mydur, Regulatory Affairs Alumna

"I learned how to organize and format an FDA submission and propose arguments in a very convincing way."
Shilpa Mydur, Regulatory Affairs Alumna

Program Description


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


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.

Time Commitment: A full-time student can complete the certificate in 12 months.

Estimated Cost: $7,000

F1 Students: [Costs for F-1 students]


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.

1. Required Courses

Fall + Classroom and Online (Blended)
Spring + Classroom and Online (Blended)
Fall Classroom
Spring Classroom
Fall Classroom
Spring Classroom
Winter Classroom
Summer Classroom
Fall Classroom

2. Elective Courses

Summer Classroom
Spring Classroom
Summer Classroom
Units: 0.5 MEDD.X405
Winter Classroom
Winter Classroom
Summer Classroom
Units: 1.5 REGL.X407
Spring Classroom

3. Required Certificate Review

Fall Online
Winter Online
Spring Online
Summer Online

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.

Program Chair

Kiran Gulati, Chair

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

Regulatory Affairs Consultant
Author, Instructor

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

Regulatory Counsel and VP Quality
Moximed, Inc.

Director, R&D
Carl Zeiss Meditec, Inc.

Vice President, Quality Assurance & Regulatory Affairs
Outset Medical, Inc.

Enroll in Program

Enroll Now

You are invited to declare candidacy in your certificate program as soon as possible so you can lock in the curriculum requirements and not be impacted by any subsequent program changes. Once you’ve declared, you have three years to complete the program.


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