+7 495 913-31-94
+7 495 913-31-95
mks@mks.ru
|
|
MEDICAL COMPUTER SYSTEM certificated the quality management system according to international standards DIN EN ISO 9001:2000, DIN EN ISO 13485:2003, and to annex V, section 3 of the Medical Devices’ Directive 93/42/ECC. Thus we can guarantee performance the requirement of these standards during development and manufactures, also we can manufacture the medical devices marking them with the CE-symbol for indicating their conformity with the provisions of the above-mentioned Directive. CE marks can be put on a medical product only after performance of all conditions of the all-European law - Directive 93/42/EEC, that should be confirmed by the corresponding certificate.
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-certificates, issued by EUROCAT Institute for Certification and Testing (Germany) and dated the 13th November, 2007 (EUROCAT is a Notified Body for medical devices in Europe with the indentifications number CE 0535), confirms that MEDICAL COMPUTER SYSTEMS has fulfilled the requirements of the:
- ISO 9001:2000 about establishing a Quality management system for the design/ development, production and distribution of medical devices;
- ISO 13485:2003 about establishing a Quality management system for the design/ development, production and distribution of active diagnostic medical devices: electrocardiographs, electroencephalographs, polygraphs;
- Annex V, section 3 of the Medical Devices’ 93/42/EEC Directive about establishing a quality assurance system for the final inspection of the specified devices
Thus MEDICAL COMPUTER SYSTEMS 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, the KARDiVAR system for stress level evaluation by a heart rate variability analysis 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. |
|
|
