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).
Aggredyne recently doubled the size of its facility as it prepares for it next growth phase and expansion of its product line, officials reported.
“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.
Aggredyne was founded in early 2011 to commercialize the AggreGuide, which is an in-vitro diagnostic test that measures how sticky a patient’s platelets are and how well the patient is responding to antiplatelet medications such as aspirin, Plavix (clopidogrel), Effient (prasugrel) and Brilinta (ticagrelor).