Medical Devices

NEW Medical Devices Certificate Program

Certificate pending academic credit approval (expected for summer 2012).

Silicon Valley is a Leading Hub of Medical Device Innovation

Medical devices include a broad array of products, from the simple tongue depressor to surgically implanted stents and in-vitro diagnostics. Altogether, the U.S. medical device market is estimated at approximately $100 billion. The Bay Area is home to one of the highest concentrations of medical device startups in the U.S., with a broad array of established companies that vary in size, core technology and therapeutic focus. There are exciting opportunities in this robust industry for professionals from a range of disciplines. 

Comprehensive Curriculum in Medical Devices

Our certificate in Medical Devices covers topics that are critical to the development and commercialization of safe and effective medical devices and in-vitro diagnostics (IVD’s). Taking a practical and hands-on approach, the courses build a solid foundation that spans product design and development, regulatory and quality issues, innovation strategy, risk management and more.

Who should Attend This Program

Experienced and aspiring medical device professionals will gain insight into the technological, regulatory and business aspects of the industry and learn what it takes to be successful in the dynamic and highly-regulated medical device industry.

Courses in this program will benefit professionals from a wide range of disciplines, specifically:

  • Those who want to enter the expanding field of medical devices.
  • Cross-development teams from medical device and IVD (in-vitro diagnostics) companies, including those in: Quality Assurance (QA), Regulatory, R&D, Product Development, Software and Hardware Engineering, Product Management, Customer Support, Product Verification & Validation, Marketing, Operations/Manufacturing and Clinical Research.

Prerequisites

There are no prerequisites to enter this program.

Recommended Course Sequence

Those new to the field should start by taking “Introduction to Medical Devices Regulation” and “Medical Device Quality Systems.”  After that, core courses can be taken in any order, with the exception of “Human Factors and Usability in Medical Device Development,” which should be taken after the “Medical Device Quality Systems” and “Risk Management for Regulated Industries” courses.

For those with experience in this field, courses can be taken in any order.

“Regulation of Medical Devices and Diagnostics” or “Medical Devices: Regulatory Strategies and Marketing Pathways” taken within the last 5 years at UCSC Extension fulfills the requirement of “Introduction to Medical Devices Regulation.” If counted toward another certificate already, an additional 1.5 units of electives need to be taken.

Benefits of Declaring Candidacy

We encourage you to establish candidacy in a certificate program early in your studies. There are substantial benefits in doing so:

  • Curriculum changes subsequent to the date your application is received will not affect your course requirements
  • Candidates will be notified of updates or special opportunities related to the program
  • Priority enrollment in fully enrolled courses

Program Contact

Enroll online now or contact the Applied & Natural Sciences Department for more
information: (408) 861-3860 or e-mail extensionprogram@ucsc.edu.

Course Schedule
Declare Candidacy

Medical Devices Certificate Requirements

Total: 17 units
Required: 5 courses
Elective: 6 units
GPA: 3.0
C or better in all courses.
Timeline: Complete minimum units/courses within 3 years.

Note: Courses completed more than five years prior to date of certificate issuance cannot be used to fulfill requirements.

How to Apply

Certificate applications can be submitted online. Simply click on the "Declare Candidacy" button above. Then, select the "Enroll" button next to the certificate title and follow the instructions.

Transfer a Course
Forms & Information
FAQs

Course Materials

Refer to your enrollment receipt for specific details about materials. Your courses may require one or both of the following types of materials:

Course Readers: Students are responsible for ordering printed course readers through our on-demand course materials service. 

Electronic Course Materials: An electronic version may also be downloaded after logging in to your course website: https://online.ucsc-extension.edu/xsl-portal

For more details on both of these options, visit our course materials page.

For information about ordering textbooks, click here.