Medical Devices
Issued by
UCSC Silicon Valley Extension
This individual is prepared to participate in the development and commercialization of safe and effective medical devices and in vitro diagnostic devices. They studied the research, design, development, regulation (including medical device quality system regulations, ISO 13485, and post market regulation), testing, and marketing of new devices and biologics. They can integrate the technological, ethical, regulatory, and business aspects of this highly regulated industry.
- Type Learning
- Level Advanced
- Time Months
- Cost Paid
Skills
Earning Criteria
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Completed five core courses: Design Control for Medical Devices; Human Factors and Usability in Medical Device Development; Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements; Regulation of Medical Devices and Diagnostics; and Risk Management for Regulated Industries; and at least two electives. Earned 17 units. Met all requirements for a UCSC Silicon Valley Certificate in Medical Devices.
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Dual Certificates can be earned in Medical Devices and one of the following: Biotechnology, Clinical Trials, or Regulatory Affairs. Details can be found at the bottom of the certificate page.