Claros Diagnostics Receives ISO 13485 Certification.WOBURN, Mass. -- Claros Diagnostics, a developer of novel point-of-care immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. systems, reported the receipt of corporate ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 13485 and CMDCAS CMDCAS Canadian Medical Devices Conformity Assessment System certificates of registration issued by the National Standards Authority of Ireland The National Standards Authority of Ireland, or NSAI, is the International Organization for Standardization (ISO) member body for the Republic of Ireland. As Ireland’s official standards body, the NSAI aims to inspire consumer confidence and protect industry (NSAI NSAI Nashville Songwriters Association International NSAI National Standards Authority of Ireland NSAI Non-Steroidal Anti-Inflamatory ). 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 (1) (Minolta-QMS, Inc., Mobile, AL) A manufacturer of laser printers founded in 1977 by Jim Busby. Initially involved with controllers for printing bar codes and labels, it entered the laser printer business in the mid-1980s and set numerous records. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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." About Claros Diagnostics, Inc. 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. A diagnostic panel for prostate cancer is the initial focus, however this first market opportunity is a bridge to the true platform nature of the technology which also encompasses infectious disease, women's health, cardiology, companion diagnostics, etc., with applications in settings throughout the world. |
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