Company news

16 October 2023

Alkor Bio Company Ltd. has confirmed its compliance with International Standard ISO 13485:2016

In October Alkor Bio Company Ltd. – Russian designer and manufacturer of ELISA, CLIA and PCR in vitro diagnostic kits and instruments - has been assessed for compliance with the International Standard ISO 13485:2016.

The surveillance audit was performed by URS (United Registrar of Systems) Certification (the Great Britain) and Certification Association Russian Register – the national leader of the independent assessment and certification of medical devices QMS.   

During the audit whole quality management system of Alkor Bio Company Ltd. has been assessed, including design and development, purchases, production (including new industrial sites of instruments production), metrological control, sales, documentation and personnel. The main goal of the audit as well as the certification itself was to confirm the ability of an organization to supply medical devices that meet all the requirements imposed by both customers and regulatory  bodies which was demonstrated during the audit.