The AI Act: An Overview
Artificial intelligence (AI) is reshaping industries, economies, and societies across the globe. While AI offers enormous potential, it also brings…
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;…
Digital Health Devices : Challenges for Regulatory Compliance
Digital Health Devices raised a lot of attention to the MedDevice community for the challenges that need to be addressed…
Artificial Intelligence and Machine Learning as Medical Device Software
Artificial Intelligence for Medical Device: new challenges for regulatory compliance.