Quality certificates obtained by Diagnostica Stago

QUALITY

QUALITY

The Quality Approach :		The CE Mark :
The quality approach covers every stage in the life of our reagents and coagulation analysers. DIAGNOSTICA STAGO has received certification ISO 13485 from the G-MED for all its activities. This approach, implies regular auditing as follows : - every year, one follow-up audit - every three years, one renewal audit DIAGNOSTICA STAGO, a member of the French In-Vitro Diagnostic Industry Federation (SRFL) is allowed to market the widest range of Haemostasis reagents and Coagulation analysers throughout the world.		On the 7th of December 1998, the Directive 98/79/CE regarding medical devices for in-vitro diagnosis was published in the Official Journal of the European Communities. This relates to reagents, equipment and accessories intended for use in laboratory tests. This Directive came into force on the 7th of June 2000 and since this date, reagents carrying the CE mark can circulate freely ithroughout the entire European Community.

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