IEC 62304:2006 – Medical Device Software
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of software used as or within medical devices. It
QMS & Medical Device Regulation
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of software used as or within medical devices. It
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