Posted in | Nanomedicine

BSI Awards ISO 13485:2003 Certification to Nanomix

Nanomix Inc., a leading nanotechnology company focused on the development of mobile diagnostic tests to enable earlier and more accurate testing in hospital and pre-hospital settings, today announced it has received International Standards Organization (ISO) 13485:2003 certification. The certification was awarded by the British Standards Institution (BSI), one of the world's leading certification bodies.

ISO 13485:2003 certification is an internationally recognized quality standard for medical devices. Nanomix's certification recognizes that consistent quality policies and procedures are in place for the development, design and manufacture of products. The certification is a key regulatory requirement for CE marking in the European Union as well as other international markets.

"Receiving the ISO12385:2003 certification demonstrates our commitment to developing and delivering product of the highest standard and is another major milestone completed in preparation for the launch of Nanomix eLab" said David Ludvigson, President and CEO.

Nanomix is targeting commercial launch of its mobile diagnostic platform in 2015 with tests for use by Emergency Departments and EMS First Responders. The first product, a critical cardiac diagnostic assay, will be a multiplexed test panel incorporating cardiac troponin cTnI. Nanomix is also developing a screening test for potentially septic patients. The Nanomix system operates directly from a whole blood sample and provides results in 10 minutes or less.

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