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February 26, 2020

Via Regulatory Focus: The Changing Role of the Regulatory Professional

This article discusses the widening range of responsibility for regulatory professionals and the increasing importance of their role to an organization’s bottom line. The author covers the value of continuously developing new skills in addition to regulatory and scientific knowledge to more effectively interface with colleagues with a variety of expertise.
February 26, 2020

China Medical Device Approval under Emergency Use

Due to a novel strain of coronavirus (COVID-19) that is spreading across the country from Wuhan city, the Chinese government has started an emergency mechanism and implemented emergency measures to fight and control the disease.  Medical devices, as one of key resources, play an important role in this outbreak.
February 19, 2020

An update to Clinical Evaluation and Clinical Investigation guidance by NMPA

In October 2019, IMDRF released three harmonized documents, Clinical Evaluation, Clinical Evidence - Key Definitions and Concepts, and Clinical Investigation were finally released. China, as an IMDRF member and president for the cycle starting in 2018, proposed this global harmonization project for clinical evaluation.

February 14, 2020

Qserve introduces FAQ Friday

We know there are a lot of questions regarding new regulations in the market, so we would like to offer our followers the opportunity to share questions and receive answers. Meet FAQ Friday! Gert Bos explains it all in his vlog.
February 13, 2020

Article 120 and its implications in the transition period

The much-dreaded date of 26 May 2020 is now only a matter of weeks away and with that, a new phase of the transition towards a full MDR implementation will begin. Read in this blog more about the latest changes in Article 120(3).
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