Senior Consultant Medical Device Project, Netherlands
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Description: Risk Management in the life cycle of the medical device or in-vitro diagnostic device is key for placing safe and effective devices on the market. Under the European Medical Device Regulation 2017/745 and In-Vitro Diagnostic Regulation 2017/746, new requirements for risk management have been introduced. By using case studies, the workshop focuses on the different steps in the risk management process from design till decommissioning, as an integral part of the design and development process. Being able to apply the requirements of ISO 14971:2019 is key in this workshop, and is practiced and explained by case studies. The program will include: Determination of hazards, hazardous situations and harms; Uniformly apply hazards, hazardous situations and harms in dFMEA, uFMEA and pFMEA; Planning and processing of post market surveillance data into the risk management file in combination with statistical techniques. Throughout the workshop input from a notified body representative on the different subjects will be provided.
After completion in this workshop participants are able to apply the risk management requirements from MDR and IVDR using ISO 14971:2019, including planning for and processing of post market surveillance data.
After completion in this workshop participants are able to distinguish hazards, hazardous situation and harms with the objective to uniformly apply them in the dFMEA, uFMEA and pFMEA and link risk levels with statistical techniques used during design verification and design validation.
After completion in this workshop participants are able to understand the expectations of notified bodies regarding the risk management requirements under the MDR and IVDR.