Presentation of the Periodic Safety Update Report for medical devices (PSUR) required by the Medical Device Regulation (UE) 2017/745
This article gives the state of the art in Cybersecurity of Medical Devices, to provide a overall view of a cybersecurity management process.
Summary of the standard IEC 62366-1 Medical devices Usability engineering: examples and methods.
Summary of the XP S99-223 standard on the management of the benefit/risk ratio of medical devices for regulatory purposes
Overview of the XP S99-223 standard