Medical Devices
Certificate Program

Medical Devices

From discovery to market

Enroll in Certificate View Individual Courses

Certificate 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

Cost: $7,000
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.

Courses

Course Units Fall Winter Spring Summer
1. Five Required Courses
Design Control for Medical Devices 2.0 + +
Human Factors and Usability in Medical Device Development 2.0
Quality Systems for Medical Devices: FDA QSR and ISO 13485 2.5
Regulation of Medical Devices and Diagnostics 3.0
Risk Management for Regulated Industries 3.0
2. 4.5 Elective Course Units Required
Global Medical Device Submissions and Strategy 1.5
Medical Device Verification and Validation 1.5
Mobile Medical Applications 0.5
Post-Market Regulatory Obligations for Medical Devices 1.5
Regulation of in vitro Diagnostics in Europe and the US 2.5
Validating Software for Medical Devices and Emerging Technologies 2.0
Value-Added Quality Audits 1.5
3. Fee for Certificate Review
Medical Devices Certificate Completion Fee None

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

MEREDITH BROWN-TUTTLEBA, RAC, FRAPS
Regulatory Affairs Consultant
Regulatorium
Author, Instructor

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
Moximed, Inc.

NIRANJAN MAHARAJHMS, BS
Director, R&D
Carl Zeiss Meditec, Inc.

JENNIFER MASCIOLI-TUDOR, MBA, BS
Vice President, Quality Assurance & Regulatory Affairs
Outset Medical, Inc.

Certificate Inquiry Form

Contact Us
Speak to a student services representative.

Call (408) 861-3860

Envelope extension@ucsc.edu

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