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.

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

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There will be a $60 fee upon acceptance into the program

Courses

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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 Online

Spring --

Summer Online
Title & Course Number

Units

Fall

Winter

Spring

Summer

Actions
Design Control for Medical Devices
(BIOL-40324)

3.00 units

Fall --

Winter --

Spring Online

Summer --
Title & Course Number

Units

Fall

Winter

Spring

Summer

Actions
Regulatory Submissions for Medical Devices
(BIOL-40325)

3.00 units

Fall In-class

Winter --

Spring In-class

Summer --
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 $60 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 $60 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: unexbio3@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
Robert Duffy

Bob Duffy Associates
Laura Guy

Regulatory Liaisons, LLC.
M.S., RAC
Angela McMahill

UCSD Health Sciences Research Compliance Program
JD, CHRC, CHC, CCRA
Al Memmolo

Dallen Medical
MBA
Katie Smith

Katie Smith Consulting
Doug Worth

Edan Instruments
MSEE, RAC

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REQUEST INFORMATION

about Regulatory Affairs for Medical Devices

From the Blog

August 08, 2017

Regulatory Affairs for Medical Devices

Certificate Benefits

Learning Objectives

Contact

Conditions for Admission

Kevin Daly

Robert Duffy

Laura Guy

Angela McMahill

Al Memmolo

Katie Smith

Doug Worth

Popular in Sciences

Applied Bioinformatics

Biology Fundamentals

Metabolic Engineering for Industrial Biotechnology

Clinical Trials Design and Management

Biostatistics

Microbial Fermentation Workshop

Introduction to Biochemistry

Clinical Trials & Regulatory Affairs

Therapeutic Discovery and Development

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