Introduction: Digital Medical Devices Regulation Direct to consumer (DTC) digital medical devices pose different challenges from regulation point of view. In this post I want to
Digital Health Devices raised a lot of attention to the MedDevice community for the challenges that need to be addressed to fully meet regulatory compliance.
Introduction In the last years, the use of Artificial Intelligence and Machine Learning software as Medical Device has increased substantially. On the other hand, the regulators
Network data server 3d cloud computing concept realistic vector illustration Eudamed is a database that will be used to monitor both the safety and performance of
Within 2020, a new standard is expected to be published: it is named ISO 20417 Medical devices — Information to be supplied by the manufacturer