Such organizations can be involved in one or more stages of the life-cycle, including development, production, storage and distribution, installation, or servicing of a medical device and development or provision of associated activities. The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. 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.
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