NuGEN Awarded ISO 13485:2003 Medical Devices Certification
Award Affirms Organization’s Commitment to Quality Systems.
San Carlos, Calif.—April 23, 2008— NuGEN Technologies, Inc., a privately held company that develops and commercializes nucleic acid amplification and labeling systems, announced today that it has been awarded the International Standards Organization’s 13485:2003 certification by TUV SUD, an engineering services firm providing international safety testing and certification services.
ISO Certification 13485:2003 defines standards for design, development, production, and distribution of medical and in vitro medical devices and components. NuGEN was awarded the certification following a rigorous audit of its quality systems established in 2006 to support the company’s customers in meeting mandated regulatory processes.
Certification is recommended for companies doing business in the global medical devices marketplace. Today, NuGEN’s amplification, fragmentation, and labeling solutions enable the biomarker signature discoveries that drive tomorrow’s clinical diagnostic advances.
“Our customers are among the world leaders in drug discovery and development and their quest to investigate mechanisms and pathologies of disease depends on products that deliver precise, consistent, and reproducible results every time,” explained NuGEN chief executive officer, Elizabeth Hutt, “As their partner in the discovery process, we share our customer’s commitment to rigorous quality standards and have ensured our processes will continue to address their growing needs.”
According to Eileen deFeo, NuGEN senior director of strategic initiatives and management representative for Quality Assurance, “Achieving ISO certification is the ultimate validation of quality systems that ensure customers can confidently include NuGEN products in their programs.”
All NuGEN amplification and target preparation products are manufactured following the now-certified quality systems. They include solutions for FFPE expression profiling (formalin-fixed, paraffin-embedded), exon analysis, and whole blood expression analysis for signature discovery.
For pricing and availability of Ovation Systems, researchers may contact NuGEN Technologies at 888-654-6544 or firstname.lastname@example.org, or visit the NuGEN website at www.nugeninc.com.
NuGEN Technologies, Inc. (www.nugeninc.com), based in San Carlos, CA, is focused on the development and commercialization of sensitive, rapid, and high-throughput nucleic acid amplification and labeling systems to enable the comprehensive analysis and discovery of biological mechanisms, cellular responses, and disease pathologies.
NuGEN, Ovation, SPIA, and Ribo-SPIA are registered trademarks of NuGEN Technologies, Inc. WT-Ovation, FL-Ovation, and Imagine More From Less are trademarks or service marks of NuGEN Technologies, Inc. All other marks are the property of their respective owners.