FREMONT, Calif., Feb. 28, 2013 /PRNewswire/ -- Zyomyx, Inc., developer of the first quantitative disposable CD4 diagnostic, has achieved ISO 13485: 2003 certification for its quality management system. Certification was awarded by BSI, one of the world's leading certification bodies.
Achieving ISO 13485: 2003 certification is a critical first step toward both WHO Pre-Qualification and a CE mark. WHO Pre-Qualification requires a quality management system to ensure Good Manufacturing Practices (GMP) and is the regulatory clearance recognized by many policy makers, global health funding organizations, and governments of developing countries. A CE mark is the regulatory clearance requirement recognized in Europe and by many other countries and global health funding organizations.
"ISO 13485 certification is a major corporate milestone for Zyomyx that moves us closer to the expected launch of our innovative CD4 point-of-care test this year," said Peter Wagner , CEO of Zyomyx, Inc. "This strengthens the confidence our customers and partners have in Zyomyx and provides a solid foundation as we adapt our novel platform technology for other clinical applications as a leader in the commercialization of highly accessible cell count diagnostics."
About ISO 13485: 2003
ISO 13485: 2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principles relate to customer focus, management, internal processes and external relationships.
About Zyomyx, Inc.
Zyomyx, Inc., a privately held diagnostics company based in Fremont, California, is an innovato
|SOURCE Zyomyx, Inc.|
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