RPS Earns ISO 13485 Certification for Quality Management System

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On March 2, 2011, Rapid Pathogen Screening, Inc. (RPS) was awarded ISO 13485 certification for its quality management system. ISO 13485 is the internationally recognized standard for the quality management systems of organizations involved in the design, development, testing, manufacture and distribution of medical devices.

In February 2011, Rapid Pathogen Screening, Inc. (RPS) successfully completed an International Standards Organization (ISO) 13485 registration audit performed by Intertek, an accredited registrar. On March 2, 2011, the company was awarded ISO 13485 certification for its quality management system. ISO 13485 is the internationally recognized standard for the quality management systems of organizations involved in the design, development, testing, manufacture and distribution of medical devices.

Earning the ISO 13485 certification demonstrates RPS’ continued commitment to provide point-of-care diagnostic products that consistently exceed the needs of our customers as well as meet the U.S. and international medical device industry regulatory requirements.

The ISO 13485 quality system certification will allow RPS to continue its international sales expansion and will facilitate product registration and distribution in many countries.

“The ISO 13485 certification is an important validation of RPS’ strong Quality System,” says Thomas Orsini, President and CEO of RPS. “This certification is also vital to the company’s plans to continue our global sales expansion of RPS point-of-care tests. RPS tests provide healthcare clinicians with a rapid and accurate diagnosis. This allows the clinician to administer the appropriate care plan, often helping to control the spread of disease and reducing unnecessary antibiotics or treatments.”

About RPS
Founded in 2004 by a family of Ophthalmologists and headquartered in Sarasota, Florida, Rapid Pathogen Screening, Inc. (RPS) is a leading developer, manufacturer and marketer of rapid, easy-to-use, point-of-care diagnostic tests. The company’s revolutionary, patented Direct Sampling Micro-Filtration (DSMF) technology and patent-pending Direct Multi-Planar Chromafiltography (DMC) technology allow clinicians to confirm patients with infectious diseases and agents, inflammatory conditions, and asymptomatic exposure to chemical warfare and bio-terrorism agents. RPS tests have superior sensitivity and specificity and can be easily performed by the clinician’s staff without extensive training or additional equipment.

For additional information, contact:
Laura Lovejoy, Manager of Business Development, RPS, 941.556.1864
http://www.rpsdetectors.com

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Laura Lovejoy