Amorfix receives ISO13485 certification
Amorfix Life Sciences announced that it has achieved ISO13485:2003 certification for its in vitro diagnostic EP-vCJDTM test for detection of aggregated misfolded proteins in variant Creutzfeldt-Jacob Disease (vCJD).
"This achievement is a significant step forward in the commercialization of our proprietary EP-vCJD(tm) diagnostic test for screening blood donations," said Dr. George Adams, CEO of Amorfix Life Sciences. "The ISO certification demonstrates we have the processes needed to manufacture and distribute the test to the international quality standards required by customers. We are on schedule to obtain a European Union CE mark and launch our first product in the first quarter of 2008."
ISO13485:2003 is an internationally recognized process-based quality management system standard for medical devices developed by the International Organization for Standardization. ISO13485 specifies requirements for a Quality Management System which demonstrate the organization's ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The management systems that are essential include staff training, customer and regulatory communication, product design and development, sourcing and purchasing of materials and services, and delivery of products and services.
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