MDxHealth’s laboratory in Nijmegen, The Netherlands has received ISO 13485:2016 certification for 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 established quality standard for manufacturers of finished medical devices and/or critical components within a medical device platform. The standard specifies requirements for a quality management system to demonstrate a company`s ability to consistently provide products that meet applicable statutory and regulatory requirements.
Dr. Jan Groen, Chief Executive Officer of MDxHealth said: “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.”