MDR Latest info When the updated ISO 10993-18 becomes a challenge Are your Medical Device materials and components appropriately characterised? When the updated ISO 10993-18 becomes a challenge More information on Medical Devices 195 days to go and still lost in the EU MDR transition? Take advantage of our last minute MDR transition checklist! 195 days to go and still lost in the EU MDR transition? More information on Medical Devices Does the demand for resources under the new MDR seem to increase tremendously? New strategies are required! Does the demand for resources under the new MDR seem to increase tremendously? More information on Medical Devices Submission Documentation - Soundness and comprehensibility are key The goal of filing a submission documentation to an authority or a notified body is obtaining a registration of a medical device. A successful... Submission Documentation - Soundness and comprehensibility are key More information on Medical Devices How to effectively apply risk management throughout the complete life cycle of medical devices When it comes to develop safe medical devices applying risk management is a central part of all design activities. A risk-based approach is often... How to effectively apply risk management throughout the complete life cycle of medical devices More information on Medical Devices
