Regulatory Affairs for Medical Devices

BIOENGR X 430.2

This course introduces and reviews the role of Regulatory Affairs (RA) in the medical device industry.

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Winter
Summer
Online
Starting at $999.00
As few as 11 weeks
4.0
3.3

What you can learn.

  • Describe the role of Regulatory Affairs (RA) in the medical device industry and its history
  • Define the U.S. and the European Union (EU) regulatory processes, and an overview on Canada and Japan
  • Describe the various regulatory agencies and how to access RA information including medical device submissions, Quality System Regulations (QSR), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and EU and FDA inspections procedures
  • Implement strategies to get products to market quickly and in a safe and efficacious fashion

About this course:

This engineering course is designed to introduce and review the role of Regulatory Affairs (RA) in the medical device industry. The RA environment embraces the regulations and standards governing product development, from its infancy through post-approval monitoring. In today's regulatory environment, products may be classified as biologics, drugs, medical devices, or a combination of the former products. In most worldwide countries, each type of product is regulated by a different RA authority and often has its own distinct regulations. This course primarily focuses on the U.S. and the European Union (EU) regulatory processes (although other countries such as Canada and Japan will be briefly reviewed). Course topics include: RA history, the various regulatory agencies, accessing RA information, medical device submissions, Quality System Regulations (QSR), Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and EU and FDA inspections. It also includes strategies to get products to market quickly and in a safe and efficacious fashion. Required course in the Medical Device Engineering Certificate.

Winter 2022 Schedule

Date & Time
Details
Format
 
-
This section has no set meeting times.
Available
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Instructor: Michael Colvin
383854
Fee:
$999.00
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ENROLL BY: Jan 3, 2022
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Notes

Enrollment limited; early enrollment advised. 

Refund Deadline
No refunds after December 20, 2021
Course Requirements
Internet access required to retrieve course materials.

Contact Us

Our team members are here to help. Hours: Mon-Fri, 8am-5pm

This course applies towards the following certificates & specializations…

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