SQI Diagnostics Inc. Receives ISO 13485 Certification

11-Jun-2008

SQI diagnostics Inc. announced that it has been awarded its ISO 13485:2003 certification for its quality management system for the Design and Development, Production, Distribution, Installation and Servicing of its In Vitro Diagnostics systems (Microarray Platforms and Consumable Kits). This milestone further reinforces SQI Diagnostics' efforts to develop and manufacture high-quality medical systems and tests for the healthcare market, according to the company.

"The certification and implementation of a Quality Management System in accordance with ISO 13485 demonstrates that we are well positioned to manufacture and distribute our SQiDworks(TM) platform and QuantiSpot(TM) panels at the standards required by our international customers," said Claude Ricks, CEO of SQI Diagnostics. "This accomplishment brings us a step closer to commercialization of our first products. We expect to complete the validation studies of our automated microarray platform and multiplexed rheumatoid arthritis test panel in the coming months."

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Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.

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Topic world Diagnostics

Topic world Diagnostics

Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.

1 whitepaper