Quality Management

Quality Management System according to the provisions of the Medical Device Directive MDD 93/42/EEC Annex II (excluding Section 4) under application of article 120: Transitional provisions, Medical Device Regulation (MDR 2017/745) for manufacturers of medical devices in the European economic area (Note: MedCom has applied, but is not yet certified for MDR). This QM system fulfills the international standard DIN EN ISO 13485 


Annex II – excluding Section 4 of Council Directive 93/42/EEC concerning medical devices

DIN EN ISO 13485 : 2016 + AC : 2017-07 EN ISO 13485 : 2016 + AC : 2016 ISO 13485 : 2016


Certified by DQS