September 23, 2013 – Aggredyne Inc., has received ISO 13485 certification for its 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 certificate demonstrates that Aggredyne has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing.
The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards. Aggredyne’s ISO 13485 certificate was awarded by National Quality Assurance (NQA).
"For any medical device manufacturer, but especially for an early-stage company, ISO 13485 certification represents a significant growth milestone," said CEO Edward R. Teitel, M.D. "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.”
Aggredyne recently doubled the size of its facility as it prepares for it next growth phase and expansion of its product line. “The larger facility will enable us to meet our growing demand as we advance to our next generation device,” said Andrew Yee, Aggredyne’s vice president of operations and manufacturing.
For more information: www.aggredyne.com