Risk management

PSUR: Periodic Safety Update Report for Medical Devices

By Guillaume Promé
Nov. 16, 2021 Regulation (EU) 2017/745, Risk management

Presentation of the Periodic Safety Update Report for medical devices (PSUR) required by the Medical Device Regulation (UE) 2017/745

Cybersecurity

Cybersecurity for Medical Devices

By Guillaume Promé
Nov. 5, 2021 Risk management, Software

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

IEC 62366-1 – Medical Devices – Usability Engineering : a Summary

By Guillaume Promé
Oct. 12, 2021 Risk management

Summary of the standard IEC 62366-1 Medical devices Usability engineering: examples and methods.

XP S 99-223

[summary] XP S99-223 – Medical Devices – Benefit/risk management

By Guillaume Promé
Sep. 29, 2021 Regulation (EU) 2017/745, 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

XP S99-223:2020 – Medical devices – Benefit/risk management – overview

By Guillaume Promé
Sep. 16, 2021 Risk management

Overview of the XP S99-223 standard