Introduction to Risk Management


Risk management is an integral part of an investigation to IEC60601-1.  Manufacturers will need to understand the concept of risk management used in IEC60601 in order to apply the standard.

Gain a high-level introduction to the requirements related to Risk Management for IEC60601-1.  This course features examples of when and how Risk Management is utilized,  explains how it is assessed during an evaluation and provides a summary of the basic requirements from ISO 14971.

This module is included in the Designing for Compliance to IEC 60601-1 3rd Ed. eLearning bundle. Click here to access the full bundle.


Upon completion of this course, you should be able to:

  • Define risk management and why it is necessary
  • Identify the standards that apply to risk management for ME Equipment and ME Systems
  • Describe the purpose of ISO 14971 and how it relates to IEC 60601
  • Identify the various steps in the ISO 14971 risk management process
  • Define the critical documentation required for ISO 14971
  • Locate the risk management requirements within IEC 60601
  • Describe what evidence of compliance is necessary and where it can be found


Learning objectives will be measured by knowledge check questions throughout and a final case study.

Target Audience

  • Product safety engineers
  • Compliance engineers
  • Product Designers
  • Regulatory approval staff
  • Production support engineers
  • Quality assurance staff
  • Technical marketing professions

Continuing Education Units (CEUs)

  • 0.1 IACET CEUs; contact your local jurisdiction for CEU recognition.
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Time Requirement


Web-Based 60 minutes $180.00

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