Is Your Medical Device Compliant With The Second Draft Of The WHO Global Model Regulatory Framework?

In mid-2016, the World Health Organization (WHO) published the 2^nd draft of Global Model Regulatory Framework for Medical Devices including IVDs.

This document is intended to provide guidance to WHO Member States in developing and implementing regulatory controls relating to medical devices to ensure the quality and safety of medical devices.

Since many modern medical devices contain software, developers of device software and applications will want to become familiar with the global framework being proposed by WHO.

Obtain a copy of the WHO Draft here: Global Model Regulatory Framework for Medical Devices including IVDs

If you need help assessing whether you are compliant with document’s framework, talk to our expert CSV consultants today.