CARLSBAD, Calif., Feb. 18 AutoGenomics, a leader in providing automated, molecular testing solutions announced today that the organization has been awarded the ISO 13485 certification in recognition of its outstanding quality management system throughout the organization. TUV SUD America Inc. was the Certification Body.
"This significant milestone comes as AutoGenomics looks to expand its increasing role in the international market and embrace global standards of manufacturing and quality assurance," said Fareed Kureshy, President & CEO. He further said, "With already 13 CE marked products now being sold in 15 countries, the ISO certification reinforces our credentials as a global leader in the molecular diagnostics marketplace."
"We have been undertaking extensive preparations for the ISO certification process and are very heartened at the fruition of our efforts," said Evelyn Lopez, Vice President, Regulatory Affairs. "AutoGenomics operates with stringent standards from design and development through manufacturing, installation and servicing of our products. The ISO certification is a guarantee of our excellence in manufacturing and ensures integrity in all of our products."
AutoGenomics Inc., a privately held company based in Carlsbad, CA, has developed the first automated, microarray based multiplexing diagnostic platform that can be used to assess disease signatures with novel genomic and proteomic markers in the area of genetic disorders, infectious disease, cancer and pharmacogenetics. With the discovery of genes and their link to various disease states the platform has the versatility to revolutionize the way patients are diagnosed, monitored and managed, leading to the era of personalized medicine. www.autogenomics.com