Software in Medical Devices, by MD101 Consulting

To content | To menu | To search

Saturday, 27 July 2013

IMDRF published a proposed document on standalone software definitions

At be beginning of june 2013, the International Medical Devices Regulators Forum (IMDRF) published a proposed document on standalone software definitions.
The goal of this document is to harmonize the key definitions related to standalone software.

Continue reading...

Friday, 23 November 2012

New GHTF essential principles: software validation added!

The Global Harmonization Task Force released an update of their guidance on Essential Principles of Safety and Performance of Medical Devices. It supersedes the last version released in 2005.

Continue reading...

Monday, 28 November 2011

New Device Classification Guidance published by GHTF: consequences for medical imaging software

The GHTF (Global Harmonization Task Force) issued a draft of a new guidance on medical device classification They recommend to implement four classes for medical devices based on intended use: from class A (lowest risk) to class D (highest risk). And they give a set of rules on how to choose the classification of the devices.

Comparison with regulations

Wait, I've already seen this elsewhere. Classification of devices in Europe (CE mark) and in Canada have systems very similar to what GHTF recommends. This is a good thing to have an ongoing harmonization process. National regulations copy what GHTF recommends and GHTF copies what national regulations require. This is a virtuous circle. Maybe one day the FDA will implement this classification system.

Continue reading...