HAYWARD, Calif., June 28 /PRNewswire/ -- Guava Technologies, Inc. today announced that it was successfully audited to the requirements of ISO13485:2003 by BSI Management Systems. With this certification, the company will redouble efforts on medical devices for the international market, covering a variety of therapy areas, beginning with HIV/AIDS.
"We are proud to receive this international recognition," said Lawrence Bruder, President and CEO, Guava Technologies. "It's a clear indication of our ability to consistently meet regulatory and customer requirements for medical devices, and reflects our intense commitment to the highest possible standards for design, development, manufacture, and service for all of our products."
"ISO certification was the first step in our initiatives to deliver quality medical devices to the global healthcare community," continued Mr. Bruder. "We can now focus on international commercialization of our new CD4 T-cell System for monitoring treatment of HIV/AIDS. We designed the system to be highly accessible to both developed and developing countries, and hope it will prove useful in fighting the global AIDS pandemic."
"We have always been committed to stringent quality standards, and are equally committed to having a positive impact on people's lives," said Todd Christian, VP Commercial Operations, Guava Technologies. "By achieving ISO certification, we can more fully leverage our patented technologies and expertise to improve the health and well-being of people around the world, beginning with the millions living with HIV."
ISO is a network of the national standards institutes of 157 countries, and ISO 13485 is an internationally recognized standard to establish the quality management systems applicable to manufacturers of medical devices. It is harmonized to FDA 21 CFR part 820.
About Guava Technologies: Guava Technologies, Inc. (http://www.guavatechnologies.com) is a private biotechnology and medical device company that designs, develops, and delivers easy-to-use, on-demand, benchtop cell analysis systems. All systems provide absolute cell counts and offer user-friendly, assay-specific analysis software to minimize time between hypothesis and results/conclusion. Ideal for a broad range of medical and biomedical applications, Guava(R) systems and reagents help scientists around the world understand life one cell at a time.
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Guava Technologies, Inc.