FDA Guideline on General Wellness Devices
The regulation of General Wellness Devices In recent years, there was a big increase in the distribution of general wellness devices. In fact, there was the need of a guideline
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; in this post I want to speak about the approach
Cybersecurity Requirements for Medical Devices and EU MDR 2017/745
Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical device sector; new guidelines to define cybersecurity requirements appeared, first by
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 to fully meet regulatory compliance. Particular attention have been given
Artificial Intelligence and Machine Learning as Medical Device Software
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 struggled to adapt the Medical
