Claros Diagnostics receives ISO 13485 certification for
point-of-care blood-test system
14 October 2009
Claros Diagnostics, a developer of novel point-of-care immunoassay
systems, has reported the receipt of corporate ISO 13485 and CMDCAS
certificates of registration issued by the National Standards Authority
of Ireland (NSAI).
ISO 13485 is an internationally recognized standard which defines the
requirements for design, development, production, and distribution of
medical devices. It validates that Claros has processes in place to
control the development and production of safe and effective medical
devices. Achieving ISO 13485:2003 certification under CMDCAS further
demonstrates corporate compliance with the Canadian QMS regulatory
requirements for medical device licensing.
“This is the culmination of a great deal of cross-functional
diligence with respect to all of our employees. It is reflective of our
mission and strategy as we set the foundation for an international
launch of our products,” said Michael J. Magliochetti, Ph.D., President
and CEO of Claros.
“We are committed to meet and exceed the expectations of the
clinicians and patients we serve and to continuously improve the
effectiveness of the quality management system under which we operate.”
Claros Diagnostics, Inc. has developed a novel medical diagnostic
system (small desktop or handheld configuration) which delivers high
performance quantitative laboratory blood test results with significant
ease-of-use allowing the transition of complex immunoassays from the
centralized reference laboratory to the point-of-care (bedside,
physician’s office, etc.).
The technology utilizes a finger-stick of whole blood, has the
inherent capability to multiplex on a single disposable cartridge, and
delivers results in minutes.
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