2007'07.02.Mon
Guava Technologies Enters International Clinical Market with ISO13485 Certification for Design and Manufacture of Medical Devices
June 29, 2007
Understanding AIDS one cell at a time
HAYWARD, Calif., June 29 /Xinhua-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.
Guava, the Guava Technologies Logo, and all other
trademarks are the property of Guava Technologies, Inc.
For more information, please contact:
Lisa English
Communications Director
Guava Technologies, Inc.
Tel: +1-510-576-1394
Email: lenglish@guavatechnologies.com
PR
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