CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
December 2017—ArcherDx has earned ISO 13485:2003 and EN ISO 13485:2012 certification from the British Standards Institution. This ISO certification indicates that the company’s quality management system maintains standards specific to medical devices, including in vitro diagnostic assays. The company will work to receive EN ISO 13485:2016 certification in 2018 per ISO guidelines, thus ensuring the company remains aligned with the current medical device regulatory environment.
ArcherDx, 303-357-9001