Medical and IVD Device Risk Management
Risk management is a key factor in assessing the safety of medical devices. MDR and IVDR requirements also require risk management to be taken into account as part of the quality system.
In this training, we cover medical device risk management from the perspective of MDR and IVDR regulatory requirements. We will also familiarise ourselves with the requirements of ISO 14971:2019 and how it is applied as part of the risk management of medical and IVD devices. This training will provide you with the skills to understand and perform risk management measures related to medical device settings. You know how to conduct a practical risk analysis and what should be taken into account when choosing a risk analysis method. SGS Fimko's Medical and IVD Device experts are familiar with MDR/IVDR requirements and their interpretation as well as risk management practices.
Training is conducted in Finnish.