Thursday 7 January 2010

Accumetrics Achieves ISO 13485 Medical Device Certification

Accumetrics, Inc., developer and marketer of the VerifyNow® System, the first rapid and easy-to-use diagnostic system for measuring an individual's response to multiple antiplatelet agents, announced today that the Company has received a certificate of registration to ISO 13485: 2003, the Quality Management System, a standard developed by the International Organization for Standardization for medical device manufacturers.

"We are extremely pleased to achieve certification to the ISO 13485:2003 standard, demonstrating our commitment to quality," said Timothy I. Still, President and CEO of Accumetrics. "With achievement of this important milestone, we can aggressively pursue our ambitious growth strategies and international expansion plans for 2010."

About Accumetrics (www.accumetrics.com)

Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.

Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient®) and clopidogrel (Plavix®)), and the GP IIb/IIIa inhibitors (e.g. ReoPro® and Integrilin®), the VerifyNow System provides a valuable tool to help physicians make more informed treatment decisions.

The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of Sanofi-Aventis. Effient is a registered trademark of Eli Lilly and Company.

2 comments:

  1. The ISO 13485:2003 Standard is a "stand alone" Standard, in light of the ISO 9001:2008 structure. The ISO/TR 14969:2004 is a Technical Report expected to give a direction on the provision of ISO 13485:2003.
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