Chembio Diagnostics, Inc. (CEMI.OB) announced in a momentous press release that they have received ISO 13.485: 2003 ISO (International Organization for Standardization) certification for the companies various technology. The main objective behind such a certification is that the company can now meet International harmonized medical device regulatory requirements for their various technology.
In order to be ISO certified, a company must exceed specific requirements established by ISO for their quality management system. A company also needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.
Lawrence Siebert, CEO of Chembio, stated, “We are proud to add this ISO certification to our other regulatory achievements which include two U.S. Food and Drug Administration approved Premarket Approval Device Applications (“PMAs”), and a product and facility license from the U.S. Department of Agriculture for our veterinary tuberculosis tests.”