Medcom

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.

 

Certificates:

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