The responsible national committee is Working Committee NA 063-01-13 AA 'Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte' ('Quality management and corresponding general aspects for medical devices') at DIN Standards Committee Medicine (NAMed). The standard has been prepared by Technical Committee ISO/TC 210 'Quality management and corresponding general aspects for medical devices' (secretariat: ANSI, USA), in collaboration with Technical Committee CEN/CLC/TC 3 'Quality management and corresponding general aspects for medical devices' (secretariat: NEN, Netherlands) with the collaboration of German experts.
