Regulatory Affairs for Medical Devices

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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.

Format

Online

*Options may vary by quarter.

Est. Cost

$3,465*

*not including textbooks

Duration

9 -15 Months*

*Varies by student and courses taken per quarter.

Certificate Benefits

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

Learning Objectives

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

APPLY NOW

There will be a $95 fee upon acceptance into the program

Courses

Download PDF

Required Courses
Title & Course Number

Units

Fall

Winter

Spring

Summer

Actions
Overview of Regulatory Affairs for Medical Devices
(BIOL-40322)

3.00 units

Fall Online

Winter --

Spring Online

Summer --
Title & Course Number

Units

Fall

Winter

Spring

Summer

Actions
Quality Management Systems for Medical Devices
(BIOL-40323)

3.00 units

Fall --

Winter --

Spring Online

Summer --
Title & Course Number

Units

Fall

Winter

Spring

Summer

Actions
Design Control for Medical Devices
(BIOL-40324)

3.00 units

Fall --

Winter Online

Spring --

Summer Online
Title & Course Number

Units

Fall

Winter

Spring

Summer

Actions
Regulatory Submissions for Medical Devices
(BIOL-40325)

3.00 units

Fall --

Winter Online

Spring --

Summer Online
Title & Course Number

Units

Fall

Winter

Spring

Summer

Actions
Post Market Topics for Medical Devices
(BIOL-40326)

3.00 units

Fall --

Winter Online

Spring --

Summer Online

APPLY NOW

There will be a $95 fee upon acceptance into the program

Admission

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.

APPLY NOW

There will be a $95 fee upon acceptance into the program

From the 'Apply Now' button, login to your student account, complete the online application, and pay the application fee if applicable. It is preferable that you create an account before proceeding if you have not already done so.

Candidates are encouraged to apply in the certificate program as early as possible to take advantage of program benefits. See Certificate FAQs for more information.

Contact

Science & Technology. Call 858-534-9353 or Email: unexbio@ucsd.edu
Conditions for Admission

To enroll in the certificate program, complete the application and, upon acceptance into the program, pay the $60 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.

Advisors

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