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
Annex II of Directive 93/42/EEC
EC Design Examination Certificate (Resorbable Implant System Resorb x®)
EC Design Examination Certificate (Aneurysm Clips)