Program Overview

Regulatory Affairs for Medical Devices Program

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. 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.

Program Overview

• The program is designed to be completed in only one year.
• It can be completed online in the convenience of your own home or office.
• Hands-on comprehensive training is designed to immerse you in the skills needed to successfully get started or advance your career.
• Courses are taught by leading industry practitioners.

Certificate Benefits

• 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.

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.

Program Details

• Duration: 9-15 months.
• Cost: $3,850 (not including textbooks).

Required Courses

Overview of Regulatory Affairs for Medical Devices

• Units: 3.00
• Cost: $745.00
• Description: This course provides an understanding of the regulatory affairs environment, how to navigate and work with the FDA, and the steps and timetable to develop and commercially market medical devices in the United States.

Quality Management Systems for Medical Devices

• Units: 3.00
• Cost: $745.00
• Description: This course provides an in-depth look into the FDA Quality System Regulation (21CFR820) and International Standard ISO 13485 for Quality Management Systems.

Design Control for Medical Devices

• Units: 3.00
• Cost: $745.00
• Description: This course provides a detailed and practical overview of the design control process for medical device design and development.

Regulatory Submissions for Medical Devices

• Units: 3.00
• Cost: $745.00
• Description: This course covers the specifics of regulatory submissions made to the FDA for the purpose of placing a medical device on the commercial market.

Post Market Topics for Medical Devices

• Units: 3.00
• Cost: $745.00
• Description: This course provides a detailed training on a variety of Post Market Topics and introduces professionals to the many typical situations they may be responsible for during the weeks, months, and years after commercialization of a product.

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 Extended Studies programs are designed to best serve college-prepared working professionals.

Certificate Guidelines

• There are five required courses in the Regulatory Affairs for Medical Device certificate.
• It is strongly encouraged 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 Fornataro McMahill, JD, CHRC, CHC, CCRA, Asst. VC Rsch Comp & Integrity (RETD), 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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