Press release: ArcherDX receives EN ISO 13485 certification for medical device quality management

Published Tue Nov 14, 2017


BOULDER, CO—ArcherDX announced today that it has earned ISO 13485:2003 & EN ISO 13485:2012 certification from the British Standards Institution (BSI). This ISO certification indicates that the company’s quality management system maintains standards specific to medical devices, including in vitro diagnostic (IVD) assays.

Specifically, the ISO 13485 certification indicates that product samples are regularly subjected to rigorous, independent testing to ensure that they comply with stringent standards for safety, product performance or reliability. Archer received ISO 13485:2003 & EN ISO 13485:2012 certification on November 06, 2017, scoped to “Design, manufacture and distribution of next generation sequencing (NGS)-based reagents and software”. The company will work to receive EN ISO 13485:2016 certification in 2018 per ISO guidelines, thus ensuring that the company remains aligned with the current medical device regulatory environment.

“We are excited about this ISO certification, which is critical for us to develop CDx and other IVD assays in the pipeline,” stated Jason Myers, Ph.D., Co-founder and CEO of ArcherDX.

About ArcherDX

ArcherDX addresses the bottlenecks associated with using NGS in oncogenic mutation detection by offering a robust platform for targeted sequencing. By combining proprietary Anchored Multiplex PCR (AMP™) chemistry with easy-to-use, lyophilized reagents, Archer NGS assays generate molecular-barcoded sequencing libraries from RNA, DNA and ctDNA. Complemented by powerful bioinformatics software, ArcherDX technology dramatically enhances identification and discovery of gene fusions, SNVs, indels, CNVs and RNA abundance. ArcherDX is ISO 13485:2003 & EN ISO 13485:2012 certified.

ArcherDX is headquartered in Boulder, Colorado.

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For Research Use Only. Not for use in diagnostic procedures. For Research Use Only. Not for use in diagnostic procedures.