MDxHealth's quality management system gets clean bill of health.
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.
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.