BioTek Certified in Accordance with EN ISO 13485

18-Dec-2012 - USA

BioTek Germany, European Coordination Center, was recently awarded certification in accordance with EN ISO 13485:2003. This certification confirms that administration, sales and distribution, warehouse management, service/repair, and installation at the subsidiary all fulfill the quality management system requirements for medical devices as set out in this standard.

BioTek's EN ISO 13485 certification guarantees that all of its products and services satisfy the requirements, and comply with the currently valid legislation, relating to medical devices.

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