Program Description

Risk Management Basics Certificate

Estimated Learning Duration of the Program:
2 hours
Program Description:

This program provides a comprehensive review of the basics of risk management, including the requirements outlined in the ISO 14971 standard.

It covers the following topics:

  • Practical setup of risk management files
  • Explanation of the different techniques to apply to risk management files
  • How to integrate risk management into quality systems
  • Overview of the implications of the ISO 14971: 2012 version

Learning Objectives:

Upon successfully completing this program, learners will be able to:

  • Identify, implement, verify, and maintain risk control measures to reduce risks associated with medical devices to an acceptable level
  • Discuss the implications of the ISO 14971: 2012 version with notified bodies
  • Implement the necessary changes in the risk management process when applicable

Price:€ 218.00

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