TGA’s Approach for Regulation of Direct to Consumer Digital Medical Devices
Introduction: Digital Medical Devices Regulation Direct to consumer (DTC) digital medical devices pose different challenges from regulation point of view;…
Introduction: Digital Medical Devices Regulation Direct to consumer (DTC) digital medical devices pose different challenges from regulation point of view;…
Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical…
Digital Health Devices raised a lot of attention to the MedDevice community for the challenges that need to be addressed…
Artificial Intelligence for Medical Device: new challenges for regulatory compliance.
Eudamed is a database that will be used to monitor both the safety and performance of medical devices distributed in…
The use of statistic for activities related to quality management System is of great importance and both ISO 13485 and…
A new standard is expected to be published in early 2021: it is named ISO 20417 Medical devices — Information…
ISO 14971 for medical device risk management was approved in December 2019. Although no significant changes on the risk management…
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