Certificate in Medical Devices Regulations

The Certificate in Medical Devices Regulations Program offers a cost-effective, and convenient way to equip you or your team with the tools and knowledge needed to progress as a regulatory professional and stay ahead of the competition.

This program is created by regulatory experts and is ideal for those who are new to the regulatory profession or medical device industry, transitioning from a related discipline or simply looking to refresh your knowledge. Designed specifically for regulatory professionals in their first five years in the field, you can customize this comprehensive and flexible program to meet your learning needs.

Elevate your certificate program by completing the Foundation in Regulatory Affairs (FRA) exam, which is included. Once you pass the exam, you will earn a credential that allows you to display a digital badge and add it to your resume.

Program Details

This certificate is achieved by completing four (4) core and five (5) elective courses.  After successfully completing all nine courses, you will receive a certificate recognizing your achievement. 

You will have twelve months (12) to complete all nine (9) courses of the program.

Core Courses 

The following four courses are required as part of the program requirements:

• Ethics
• Global Regulatory Strategy for Medical Devices
• Medical Devices: Definition & Lifecycle
• Role of the Regulatory Professional

Elective Courses

You also choose five courses from our designated portfolio of programs that have a M allotted to them. These courses are considered part of our Medical Device certificate. You are welcome to add on additional courses outside the five “M” you select at an additional charge.

Download the Course Catalog
 

Foundation in Regulatory Affairs (FRA) Exam: Introduction to Medical Devices

Here are a few key things to know about the included FRA exam. If you want to know more about this credential, please visit the FRA page.

• You have 12 months to take the FRA exams.
• The FRA exams are separate from the end of course assessments.
• Materials may NOT be used during the exam.
• You will have 5 attempts to pass each FRA exam.
• Exam results will be provided at the end of each exam attempt.

Registration

Note: If you have already registered for a RAPS Online University course that is included as part of this certificate program, you may be able to apply it toward the program requirements and registration fee. Contact us to see if your course(s) qualifies.

• Register by Fax/Mail