Regulatory Affairs for Medical Devices

About the Regulatory Affairs for Medical Devices Program

Overview

Certificate Benefits

Learning Objectives

Explore 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

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 ...

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Upcoming Start Dates:

September 23, 2024

Typically Offered: Fall, Spring

Quality Management Systems for Medical DevicesBIOL-40323

Units: 3.00

$745

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...

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Upcoming Start Dates:

September 23, 2024

Typically Offered: Fall, 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...

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Upcoming Start Dates:

January 13, 2025

Typically Offered: Winter, Summer

Regulatory Submissions for Medical DevicesBIOL-40325

Units: 3.00

$745

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...

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Upcoming Start Dates:

January 13, 2025

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 ...

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Upcoming Start Dates:

September 23, 2024

Typically Offered: Fall

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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

June 14, 2021

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Clinical Trials instructor Suzan Olson knows that changing things up to follow your passion is a good thing. She's enjoyed three successful careers centered around helping others.

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Biotech is big, and getting bigger fast.

March 17, 2016

Assuring quality at every step

As the vice president of qualiy assurance for Sorrento Therapeutics, Shay Tabani's job is to make sure the medicines made by or on behalf of her company meet the quality standards they purport to possess and are fit for their intended use.

April 27, 2015

Considering a career in biotech project management?

The Biotechnology Project Management specialized certificate, offered through UC San Diego Extension, helps to bridge the current industry hiring gap by education qualified candidates for biotech businesses.

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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.

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Regulatory Affairs for Medical Devices

Page Tools

About the Regulatory Affairs for Medical Devices Program

Courses

Delivery Method

Overview of Regulatory Affairs for Medical DevicesBIOL-40322

Upcoming Start Dates:

Quality Management Systems for Medical DevicesBIOL-40323

Upcoming Start Dates:

Design Control for Medical DevicesBIOL-40324

Upcoming Start Dates:

Regulatory Submissions for Medical DevicesBIOL-40325

Upcoming Start Dates:

Post Market Topics for Medical DevicesBIOL-40326

Upcoming Start Dates:

Conditions for Admission

Certificate Guidelines

Related Documents

Advisory Board

Related Articles

Keeping It Fresh: UCSD Extension Clinical Trials Instructor On Reinventing Your Career

On the Rise: The Business Side of Biotech

Assuring quality at every step

Considering a career in biotech project management?

Programs you may also like:

Clinical Trials Design and Management

Regulatory Affairs Essentials

Clinical Trials Administration

Stay Updated

Interested in the Program?

Interested in the Program?

Ready to get started?

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