Risks: definitions, major types and management methods. General guide, applicable to all risks (health, climate, professional, etc.)
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