Software Classification: Insights in EU Guidance
The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!
Overview of the related regulatory requirements, Safety concepts, Testing requirements, Labelling requirements, Related Usability and Home healthcare requirements
In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.
In this article we give an overview of the software life cycle of medical devices and the corresponding standards.