eZono gains prestigious DEKRA CE-certification

The eZono quality team’s hard work on implementing a world-class quality management system paid off as German DEKRA officially granted eZono AG its prestigious certificate according to ISO 13485:2003 + AC:2007 with certification number 51195-10-00. Furthermore DEKRA has certified the eZono 3000 according to annex II, section III of the directive 93/42/EEC as a medical device (class IIa). Thus the eZono 3000 gains the CE certificate and is ready to sell in Europe and most global territories.

In order to gain this prestigious designation, eZono’s quality team not only has implemented a thorough quality process but also the eZono 3000 has been tested by Carl Zeiss in Jena for safety.  The quality requirements have met there the famous German thoroughness. As a result the eZono 3000 has endured cruel tests in climate chambers, drop tests, got hit by iron balls etc. to ensure patient safety. Thus the system is not only produced in Germany but its quality is audited and certified by the German leader in quality, DEKRA.