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GeneNews Quality Management System receives ISO 13485 accreditation
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GeneNews
: 12 March, 2008 (Company News) |
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GeneNews’ Quality Management System, which covers the design and development of in-vitro diagnostic (IVD) test kits used in the management of colorectal disease status in a laboratory setting, has met the requirements of the ISO 13485:2003 standard. |
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The certification was obtained following a successful audit in December 2007 carried out by TUV SUD America.
'The implementation of our quality management system has established a solid foundation that will facilitate regulatory approval of our products on a global basis,' said K Wayne Marshall, MD, PhD, president and chief executive officer of GeneNews. 'This ISO accreditation reflects our commitment to quality and is an important milestone in the commercialisation strategy for our products.'
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