Early in the commercialization process, TearLab received company-wide certification to ISO 13485:2003. Achievement of ISO certification demonstrates TearLab's corporate commitment to quality in the design and manufacturing of its medical devices.
ISO, the International Organization for Standardization, is a worldwide federation of national standards bodies created to set standards for similar technologies in different countries. Details about ISO and its standards can be found at http://www.iso.org.
The ISO 13485:2003 standard specifically focuses on the unique and rigorous requirements for companies involved in the development of medical devices.
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