Medical Devices & Surgical Technology Week
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Accreditation
Facility receives quality system certification to ISO 13485:1996
July 25th, 2004
Calypte Biomedical Corporation (CYPT), a developer, manufacturer and marketer of HIV diagnostic tests, announced that its Rockville, Maryland manufacturing facility has successfully passed its quality system audit to obtain certification of its quality system to the international standard, ISO 13485:1996. A comprehensive, 2-day examination against the requirements of the ISO 13485 standard was conducted by an independent auditor. The ISO 13485 standard specifically addresses the application of quality system principles to medical device products. Regulatory authorities in several countries around the world such as U.S. FDA, Health Canada, China, the...
Source: Medical Devices & Surgical Technology Week (2004-07-25)
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