Our quality assurance system complies with the European Directive 98/79/EG for In Vitro Diagnostic Medical Devices and the Quality Assurance System EN ISO 13485 since 2003.

We will be further maintaining it without active certification.

The further compliance of our Quality Assurance System also without active certification will be explicitly internally assured.

Certificates held since 2003 - 2014 (TÜV-SÜD Product Services GmbH, Germany):

Reference: EC Certificate No. V1 09 02 51257 005, Full Quality Assurance System (Annex IV, section 3 of the Directive 98/79/EC on in Vitro Diagnostic Medical Devices), valid until 22.01.2014 and not extended.

Reference: EN ISO Certificate 13485:2012/AC:2012 Q1N 13 01 51257 007 valid until 31-12-2015 and terminated by us by  July 31st, 2014.