Quality Management

MedCom has established and maintains a quality management system as required by the Medical Device Directive MDD 93/42 Annex II for manufacturers of medical devices in the European economic area. This quality management system fulfills the international standard DIN EN ISO 13485:2003.


Annex II – excluding Section 4 of Council Directive 93/42/EEC
concerning medical devices
EN ISO 13485:2012 + AC:2012