TRAINING | EN 14971 Risk Management

Speaker: Dr Lydie Moreau

Training Objectives

  • Dive into the main standard, key theoretical aspects and methodologies for risk management
  • Use the main risk management tools (PHA, FMEA)
  • Build a risk analysis through the example of a medical device
  • Know how to build a risk management file together with the SOP on risk management

Training Content

  • Overview of theoretical aspects of risk management
  • Exercise: Filling a PHA for a medical device example; discussion around IVD specificities
  • Theory on FMEA methodology
  • Exercise: Filling the risk analysis matrix using the FMEA methodology for a medical device example; discussion around IVD specificities
  • Theory on risk acceptance criteria and mitigation measures
  • Exercise: Completing the risk analysis matrix with mitigation measures for the medical device example
  • SOP and Risk management file (plan/ report)

Training Format

  • Presentations with interactive discussions through several exercises
  • End of training assessment

Price

EUR 625 incl. course material and certificate

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