> About DDD > DDD history > QA > Ownership
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QA
DDD is subject to the demands of the USA's FDA (Food and Drug Administration), as well as to European requirements, including the European Medical Device Directive (MDD).
DDD has implemented a quality management system in accordance with the FDA's 21 CFR 820 and complies with the requirements stipulated in DS/EN ISO13485:2003, MDD and the FDA's QSR. DDD is CE certified, has Annex II approval and is therefore entitled to manage internal CE marking of its products.
DDD is audited by the FDA, SEMKO and DGM (Danish Approval of Medical Equipment).
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