Software

Team-NB guidance for software qualification under the IVDR

By QualitiBot
Jun. 30, 2025 • Software

The Team-NB guide “Software Qualification Under IVDR: TeamNB Guidance on IVD Software Classification and Notified Body Expectations” (v2, June 2025) provides practical clarification on the qualification and classification of in vitro diagnostic software (IVD) under Regulation (EU) 2017/746 (IVDR).

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 62304 Medical device – Software life cycle

By Guillaume Promé
Oct. 21, 2021 • Software

IEC 62304 Medical device – Software life cycle defines the life cycle requirements for medical device software, the set of processes, activities, and tasks described in this standard.