MDxHealth, a multinational healthcare company, has received ISO 13485:2016 certification for its laboratory in Nijmegen, The Netherlands. The ISO certification ensures best practice in the design, development, manufacture and distribution of in vitro molecular diagnostic products, as well as client services and service testing for molecular diagnostic detection of oncological diseases.
Dr Jan Groen, Chief Executive Officer of MDxHealth, commented: “ISO certification of our Dutch operation is an important milestone and a key step for our in vitro diagnostics strategy for Europe and other international markets. Under this certification we can develop, manufacture and distribute in vitro diagnostic (IVD) products, and now we can begin global marketing and distribution of our SelectMDx IVD kit over the course of the coming year”
ISO 13485:2016 is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices and design, develop and provide related services or component parts that are used in medical devices.
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