+7 495 913-31-94
+7 495 913-31-95
mks@mks.ru
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MEDICAL COMPUTER SYSTEMS certificated the quality assurance system according to annex VI, section 3 of the Medical Devices' Directive 93/42/EEC. Thus we can manufacture the medical devices marking them with the CE-symbol for indicating their conformity with the provisions of the above-mentioned Directive. The CE is the abbreviation of the French phase "Conformité Européene" (CE), which literally means "European Conformity", and allows a manufacturer freely distribute the CE-marked products within the European Union without additional quality testing or approvals.
The CE-certificate, issued by EUROCAT Institute for Certification and Testing (Germany) and dated the 10th November, 2006, confirms that MEDICAL COMPUTER SYSTEMS has fulfilled the requirements of the 93/42/EEC Directive about establishing a quality assurance system for the final inspection of the specified devices and, thus, has provided the high quality and safety for the patients and operators.
The issued CE-certificate covers the HeartVUE system for non-invasive screening of heart and also some other devices specially manufactured for our customers. Soon these products will be marked by the CE-symbol and the Evidence of conformity will be included into the products’ delivery set. |
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