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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