All our in vitro diagnostics have been manufactured according to Annex III of the European Directive 98/79/EG and are CE signed. 34 products are FDA cleared (Food and Drug Administration).

From the very beginning AESKU.DIAGNOSTICS has established a quality management system for the design/ development, production and distribution of in vitro diagnostics according to ISO 9001:2000. We gained our first certification in 2001 by the Notified Body EUROCAT  -  Institute for Certification and Tesing( Registration No.0535).

In 2004 AESKU.DIAGNOSTICS was one of the first companies in Germany which were certified according to the at that time new released ISO 13485:2003 - Quality management systems- requirements for regulatory purposes. This standard was developed on the basis of ISO 9001:2000, but has a strong focus on the harmonization of regulatory requirements for medical devices manufacturers with a quality management. This is realized by integrating legal requirements additionally to customer requirements.

Since ISO 13485 is a specific standard for the medical devices producing industry embrassing the ISO 9001:2000, we decided in 2009 not to attain the ISO 9001:2000 recertification anymore.
 
To extend our international distribution AESKU.DIAGNOSTICS has achieved the ISO 13485 CMDCAS certification in 2006, which is necessary for the distribution of our products in Canada.

The CMDCAS certification was realized by the Notified Body DQS-Deutsche Gesellschaft zur Zertifizierung von Managementsystemen (Registration No. 0297). Licences for more than 25 products were issued by Health Canada. More products will be licenced soon. 

Moreover since 2006 our ISO13485 certification gained authentication for distribution in Taiwan, which was shown by an audit carried out by the Notified Body mdc - medical devices certification GmbH (Registration No.0483).