Speaker: Dr Lydie Moreau
- 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.
- 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.
- 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