IRWINDALE, CA – January 30, 2013 – GeneFluidics, Inc., a biotech company that designs, markets and manufactures automated testing equipment based on proprietary electrochemical-based molecular analysis and an advanced engineering platform, today announced that it has received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices.
The ISO 13485:2003 certification covers the design, development, production, sales and service of GeneFluidics’ electrochemical sensor chips and reader platform. This certification demonstrates that GeneFluidics has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing.
“Obtaining ISO 13485 certification is a significant step forward for GeneFluidics as we work to bring our revolutionary detection platform to the medical diagnostics market,” said Vincent Gau, CEO and President of GeneFluidics, Inc. “As the gap between cutting-edge technology in research and medicine continues to widen, we are committed to closing the technology gap by bringing our revolutionary detection methods to medical facilities around the world. Our quality system provides a solid foundation upon which we and our partners will develop commercial applications for our diagnostic technologies.”
The ISO (International Organization for Standardization) is the world’s largest developer and publisher of international standards. GeneFluidics’ ISO 13485:2003 certificate was awarded by NSF International.
GeneFluidics was incorporated in 2001 to develop a fast, accurate, and simple testing system for improving worldwide health. By integrating novel bionano electrochemical technologies, the company’s revolutionary sensor platform enables bioassays to be performed in under an hour with sensitivity to picogram/ml concentrations for immunoassays and femtomolar concentrations for genetic assays, without the use of PCR.
For more information on GeneFluidics, contact:
Vincent Gau, President/CEO
845 Meridian Street, Irwindale, CA 91010
Phone: 626 263-3060