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.
further compliance of our Quality Assurance System also without active
certification will be explicitly internally assured.
held since 2003 - 2014 (TÜV-SÜD Product Services GmbH, Germany):
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.
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.