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Regulatory Affairs for Medical Devices

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About the Regulatory Affairs for Medical Devices Program

Medical device development is a dynamic area for professionals considering a career in regulatory affairs and can be as simple as a Band-Aid or as highly complex as lifesaving robotic equipment. Medical devices are increasing in complexity and becoming ubiquitous in the medical field. More recently, the convergence of medical devices with other industries has propelled growth and required more professionals to learn regulations. New products built from a combination of information technology and software enabled medical devices have expanded the need for those involved to learn regulatory requirements, including engineers and other technical associates. Additionally, a convergence of medical devices and drugs brings new treatment opportunities to healthcare, including drug coated stents used for cardiovascular procedures. The advent of such combination products make it necessary for therapeutics professionals involved in regulatory affairs to also become knowledgeable of regulations that apply to such devices.

The Regulatory Affairs for Medical Devices certificate provides professionals with the essential knowledge to work in this highly regulated environment and the process needed to develop medical devices from concept to commercialization.

  • Program designed to be completed in only one year
  • Complete all courses online in the convenience of your own home or office
  • Hands-on comprehensive training designed to immerse you in the skills needed to successfully get started or advance your career
  • Courses taught by leading industry practitioners
  • Understand the overall product development life cycle
  • Understand how to work proactively with the FDA
  • Understand how a quality management system works within a medical device company
  • Understand the overall design control process and risk analysis
  • How to prepare a 501(k) submission to the FDA
  • How to perform post market surveillance to insure safety
Format: Online

Options may vary by quarter.

Estimated Cost: $3,465

not including textbooks

Duration: 9 -15 Months

Varies by student and courses taken per quarter.

Contact
Department
Science & Technology
Phone
858-534-9353
Email
unexbio@ucsd.edu

Courses

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

Overview of Regulatory Affairs for Medical DevicesBIOL-40322

Units: 3.00

TBD

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

Quality Management Systems for Medical DevicesBIOL-40323

Units: 3.00

$675

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

$675

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:

Spring

Post Market Topics for Medical DevicesBIOL-40326

Units: 3.00

$675

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:

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.