The scope of our well established quality management system encompasses development and manufacture of gamma camera systems. Orbotech’s quality management system conforms with the requirements of the FDA's QSR 21 CFR 820, DS/EN ISO13485:2003, and the European Medical Devices Directive (93/42/EEC). Orbotech is CE certified, has Annex II approval and is therefore entitled to manage internal CE marking of its products.
Orbotech is audited by the FDA, SEMKO and DGM (Danish Approval of Medical Equipment). |
Company Overview
