Length: 2 Days
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FMEA FOR MEDICAL DEVICES

FMEA FOR MEDICAL DEVICES course helps you to use Failure Mode and Effects Analysis, a wide spread method in root cause failure analysis and quality management. Learn how FMEA is used by medical device manufacturers to prevent medical devices and product errors and thus, increase product safety.

FMEA FOR MEDICAL DEVICES

Who Should Attend

This course is designed for software and hardware engineers, quality assurance, testers, managers, and and employees with little or no FMEA experience. The course is also useful for those who have experience with FMEA but have never had any formal training.

Participants will learn how to use FMEA process applied to medical devices:

  • Identify the potential failures and the associated relative risks designed into a product or process
  • Prioritize action plans to reduce those potential failures with the highest relative risk
  • Track and evaluate the results of the action plans

What You Will Learn

  • Failure Mode and Effects Analysis (FMEA) approach
  • Different types of FMEA, for medical devices: Design and Process FMEA
  • The main function of the FMEA
  • FMEA and risk management
  • Examine known causes and unknown effects
  • How to eliminate chronic problems

How You Will Benefit

  • Apply different types of FMEA including Product FMEA, System FMEA, Design FMEA and Process FMEA.
  • Apply FMEA and risk management process to medical devices.
  • Make decisions based on failure modes and their severity.
  • Gain support for Failure Mode and Effects and Criticality Analysis (FMECA) and corrective and preventive action.

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