ISO 14971: Risk Management for Medical Devices


This course is designed to provide you with an overview of the application of Risk Management activities for medical device product safety through implementing the ISO 14971 International Standard for Risk Management. This course reflects EN ISO 14971:2012, which became a European harmonized standard in 2012.

After completing this course, you will be able to:

  • Recognize Risk Management’s role towards medical devices product safety.
  • Understand the elements of the risk management process.
  • Recognize the purpose and content for the Risk Management plan and report.
  • Identify tools that may be applicable to use in the Risk Management Process.
  • Recognize Risk Management tasks that are applied at various stages of the product lifecycle.
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Time Requirement


Web-Based 45 minutes

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