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Aggredyne achieves ISO 13485 certification for medical device

US-based Aggredyne has obtained ISO 13485 certification for implementing rigorous quality control program related to the manufacture of the AggreGuide 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 certification was awarded by National Quality Assurance (NQA).

Aggredyne CEO Dr Edward R Teitel noted for any medical device manufacturer, but especially for an early-stage company, ISO 13485 certification represents a significant growth milestone.

"This designation, along with our previously earned CE Mark, recognizes Aggredyne’s commitment to provide our customers with outstanding, high quality products and puts us on a path to increase international sales," Dr Teitel added.

Recently, the company has doubled the size of its facility in order to cater to its expanding product line and for its future growth.

Aggredyne operations & manufacturing vice president Andrew Yee said the larger facility will enable the company to meet its growing demand as it advance to its next generation device.