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Regulatory Affairs for Medical Devices

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About the Regulatory Affairs for Medical Devices Program

Courses

Delivery Method
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  • Live Online
  • In-Person
  • Online
  • Hybrid

Overview of Regulatory Affairs for Medical DevicesBIOL-40322

Units: 3.00

$745

The healthcare industry is dynamic and full of exponential growth. In this innovative and regulated industry, it is essential for medical device professionals to understand the business, science and ...

Upcoming Start Dates:
Typically Offered: Fall, Spring

Quality Management Systems for Medical DevicesBIOL-40323

Units: 3.00

$725

The cornerstone in the efficient manufacturing of a medical device is the implementation of a quality management system. Medical Device companies are required to develop a QMS that conforms to the reg...

Upcoming Start Dates:
Typically Offered: Spring

Design Control for Medical DevicesBIOL-40324

Units: 3.00

$745

Developing a new medical device for commercialization is a complex process. The FDA has guidelines that provide a framework for designing and manufacturing medical devices. This course will provid...

Upcoming Start Dates:
Typically Offered: Winter, Summer

Regulatory Submissions for Medical DevicesBIOL-40325

Units: 3.00

$675

Are you ready to enter your medical device into the commercial marketplace? This course covers the specifics of regulatory submissions made to the FDA for the purpose of placing a medical device on t...

Upcoming Start Dates:
Typically Offered: Winter, Summer

Post Market Topics for Medical DevicesBIOL-40326

Units: 3.00

$745

Once a medical device is commercialized, FDA requirements mandate that a company must perform Post Market Surveillance (PMS) to ensure public safety and efficacy. This course will provide a detailed ...

Upcoming Start Dates:
Typically Offered: Fall, Spring
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Conditions for Admission

To enroll in the certificate program, complete the application and, upon acceptance into the program, pay the $95 certificate fee. Although programs are open to all adult learners, UC San Diego Extension programs are designed to best serve college-prepared working professionals. Where program capacity is limited, applicants with this profile will receive preference for admission.

Certificate Guidelines

There are five required courses in the Regulatory Affairs for Medical Device certificate. It is strongly encourages that students take the Overview of Regulatory Affairs for Medical Devices course first.

Advisory Board

Kevin Daly

Consultant

Robert Duffy

President

Bob Duffy Associates

Laura Guy, M.S., RAC

Principal

Regulatory Liaisons, LLC.

Angela McMahill, JD, CHRC, CHC, CCRA

Executive Director, Research Compliance and Integrity

UCSD Office of Research Affairs

Al Memmolo, MBA

Chief Operating Officer

Dallen Medical

Katie Smith

Consultant

Katie Smith Consulting

Doug Worth, MSEE, RAC

Senior Director

Edan Instruments

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This certificate requires an application before taking any courses. There will be a $0 fee to apply to this program. Students will also be required to pay a $95 certificate fee upon enrollment into the program after acceptance. View the complete Certificate Registration and Candidacy Guidelines.