Kleinostheim, 19 June 2006 – curasan AG (WKN 549 453) is now certified in accordance with the new standard DIN EN ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.

The new quality management system meets not only the full range of requirements stipulated by European laws governing medical devices but also those specified by the US Food and Drug Administration (FDA). Another advantage associated with the new EU standard is that it speeds up the process of applying for product certifications in a number of non-European countries. In some countries, such as Canada , this new standard has even become an essential prerequisite for official product approval.

“The high quality of our products is attributable, among other things, to the optimised processes established within our company”, says CEO Hans Dieter Rössler. “The complete realignment of our quality management system throughout the Group represents another milestone for curasan, along with the recent pan-European approval of our dental implant system REVOIS. Thus, we are now also perfectly equipped regarding further approvals for future growth within the international arena.”