Risk management and risk analysis for medical devices according to ISO 14971:2019

The importance of risk management in medical technology will continue to grow in the future. Not only ISO 13485, but also the MDR and IVDR are based on sound risk management. A risk management system is and remains a central legal requirement for all medical device manufacturers worldwide. A systematic risk management according to ISO 14971 helps to fulfil these requirements. After attending this seminar, you will know the basics of risk management for medical devices according to the applicable standards, based on the ISO 14971:2019 standard. In addition, you will learn about the innovations of the updated ISO/TR 24971:2020 guide. You will be able to correctly implement the risk management process in your company. You will know the objectives of the risk management plan and how to proceed with the risk analysis and how to properly document results. Using concrete case studies, you will have ample opportunity on the second day to put the theoretical knowledge you have learned into practice step by step and to discuss any questions and difficulties that arise with the experts.