Is Your Medical Device Compliant With The Second Draft Of The WHO Global Model Regulatory Framework?
By Deb Bartel,
This post was recently updated on September 19, 2018
In mid-2016, the World Health Organization (WHO) published the 2nd 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.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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