IEC 82304-1 and its Application for Stand-Alone Software
IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of software-based medical devices. While these two standards may appear similar at first glance, they actually
IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of software-based medical devices. While these two standards may appear similar at first glance, they actually
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software . In fact, every company focusing on medical device or pharmaceutical business
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
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