Risks definition, types, evaluation and risk management
Risks: definitions, major types and management methods. General guide, applicable to all risks (health, climate, professional, etc.)
Risk management
PSUR: Periodic Safety Update Report for Medical Devices
Presentation of the Periodic Safety Update Report for medical devices (PSUR) required by the Medical Device Regulation (UE) 2017/745
Cybersecurity for Medical Devices
This article gives the state of the art in Cybersecurity of Medical Devices, to provide a overall view of a cybersecurity management process.
IEC 62366-1 – Medical Devices – Usability Engineering : a Summary
Summary of the standard IEC 62366-1 Medical devices Usability engineering: examples and methods.
[summary] XP S99-223 – Medical Devices – Benefit/risk management
Summary of the XP S99-223 standard on the management of the benefit/risk ratio of medical devices for regulatory purposes
XP S99-223:2020 – Medical devices – Benefit/risk management – overview
Overview of the XP S99-223 standard