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Aggredyne Earns ISO 13485 Certification for Medical Device


8/30/2013 10:19:11 AM

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HOUSTON--(BUSINESS WIRE)--Aggredyne, Inc., a Houston-based biomedical diagnostics company that is defining a new standard for platelet function, has received ISO 13485 certification for its rigorous quality control program related to the manufacture of the AggreGuideTM family of platelet function analyzers. The ISO 13485 certification covers the design, development, production, sales and service of the AggreGuide instrument and reagent cartridges. The certificate demonstrates that Aggredyne has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing.

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