We have implemented a total quality management system certified according to DIN EN ISO 13485, DIN EN ISO 9001 and the European legislation concerning medical devices. Of course, relevant national regulations have been taken into account as well - such as the requirements issued by the Food and Drug Administration (FDA) or the Canadian legislation.
Certificates for download
DIN EN ISO 9001 : 2015
Annex II of Directive 93/42/EEC
EC Design Examination Certificate (Resorbable Implant System Resorb x®)
DIN EN ISO 13485 : 2016
Annex II of Directive 93/42/EEC
DIN EN ISO 13485 : 2016
Annex II of Directive 93/42/EEC
ISO 13485 : 2003 + Cor. 1 : 2009
DIN EN ISO 13485 : 2016
Annex II of Directive 93/42/EEC
DIN EN ISO 13485 : 2016
Annex II of Directive 93/42/EEC