BioTek Germany 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 manufacturing facility and headquarters in Winooski, Vermont is similarly certified in accordance with EN ISO 13485.
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.
Thomas Brunner, Managing Director of BioTek Instruments, GmbH, explains, "Medical technology products must fulfill the most rigorous safety criteria. The fact that our quality management system complies with EN ISO 13485 - which goes above and beyond the requirements of ISO 9001 - proves that we are committed to ensuring quality and efficiency. It also provides our customers with documentary evidence that our development processes and methods meet the highest standards in the field of medical technology."