Speaker: Dr Lydie Moreau

Training Objectives

  • Be able to implement the requirements of ISO 14971 in combination with the IVD Regulation ((EU) 2017/746, IVDR) for in vitro diagnostic medical devices.
  • Be able to integrate the requirements of ISO 14971 and of the IVDR in the Quality Management System.
  • Be able to plan, implement and document risk management activities, in a practical way using a systematic and consistent approach.
  • Be able to conduct risk analyses for in vitro diagnostic medical devices in accordance with ISO 14971.

Training Content

  • Regulatory framework (EN ISO 14971:2019/A11:2021, ISO/TR 24971:2020 and IVDR)
  • Implementation of ISO 14971 and of the IVDR into the Quality Management System
  • Risks Management techniques (Preliminary Hazard Analysis; Fault Tree Analysis; Failure Mode Effect (and Criticality) Analysis)
  • Harms that are specific to IVDs
  • Methods for the identification of hazards
  • Risk analysis process, including
    • Identification of hazards
    • Risk estimation
    • Identification of risk control measures
    • Assessment of residual risks
    • Evaluation of the overall residual risk
  • Benefit-risk determination
  • Review of risk management
  • Post-market surveillance and risk management
  • Compiling the Risk Management File, as part of the IVDR Technical Documentation
  • Hands on exercise on example


Have a good understanding of the IVD development, manufacturing or use.

Training Format

  • Presentations with interactive discussions
  • Group and individual exercises
  • End of training assessment

Who Should Register?

  • Manufacturers of in vitro diagnostic medical devices
  • Employee participating to Risk Management of IVDs
  • Employee conducting development and manufacturing of IVDs
  • Safety officers / PRRC as per Article 15 of the IVDR
  • Employee working in the field of IVDs Quality Management
  • Employee in Regulatory Affairs in charge of assessing the compliance of the Technical Documentation with IVDR
  • EU Representatives


EUR 775 including course material and certificate


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