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.

Certificates:
         
  Annex II – excluding Section 4 of Council Directive 93/42/EEC concerning medical devices   Annex to Certificate
								Certificate registration No.: 276701 MR2, Certificate unique ID: 170531065   Certificate DIN EN ISO 13485:2001    
               
      CMDCAS    
               
  Certified by DQS