BioImagene receives license from the State of California, Department of Public Health (CDPH) to manufacture medical devices for digital pathology
Cupertino, CA, Wednesday,
October 1, 2008
BioImagene, a leading provider of affordable and innovative
digital pathology solutions, announced that it has received
a license by CDPH to manufacture medical devices in the State
of California.
The license from CDPH demonstrates BioImagene’s compliance
with quality system regulations. BioImagene earlier received
the ISO 13485 certification for its Quality Management System
(QMS) in June 2008.
The state of California has a comprehensive medical device
protection program that both complements and supplements
the federal medical device program. BioImagene received
their license after a rigorous audit conducted by food and
drug branch (FDB) of the CDPH.
Mr. Mohan Uttarwar, BioImagene CEO said. “Acquiring
this license is another milestone for the company’s
quality program. We are demonstrating our continued commitment
and compliance to FDA quality system regulations (QSR) and
ISO 13485 requirements.”
Mr. Indu Lakshman, Director, Quality Assurance said, “CDPH
has a proactive medical device regulatory program that seeks
to provide value for both consumers and industry. This certification
enables the company to manufacture medical devices in the
state of California. “
BioImagene develops and sells fully integrated hardware
and software systems to acquire, view, share, manage, archive
and analyze tissue images in a pathology laboratory. The
company’s goal is to provide affordable, comprehensive
digital pathology solutions for every pathologist in every
hospital and laboratory worldwide.
About BioImagene
BioImagene is the leader in providing innovative and affordable
digital pathology solutions for clinical diagnostics and
drug discovery. BioImagene products are FDA - cleared for
specific clinical applications, and are intended for research
use for other applications. www.bioimagene.com.
Media Contact: Suchi Parth 408 207 4285
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