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MDxHealth Receives ISO 13485:2016 Certification for Dutch Laboratory
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Key step for MDxHealth's in vitro diagnostic (IVD) strategy in Europe
Certification enables development, manufacturing and distribution of IVD products
IRVINE, CA, and HERSTAL, BELGIUM, December 16, 2016 - MDxHealth SA (Euronext: MDXH), announces that its 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.
"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," reported Dr. Jan Groen, Chief Executive Officer of MDxHealth. "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."