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
ISO 50001: 2011
Annex II of Directive 93/42/EEC
EC Design Examination Certificate Resorb x®
EC Design Examination Certificate CHS Resorb Mg
DIN EN ISO 13485 : 2016
Annex II of Directive 93/42/EEC
ISO 13485 : 2016 (MDSAP Audit Model Edition 2)
DIN EN ISO 13485 : 2016
DIN EN ISO 13485 : 2016
Annex V of Directive 93/42/EEC