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InDevR Receives ISO 13485:2003 Certification

NEW YORK (GenomeWeb) – InDevR this week announced that it has received ISO 13485:2003 certification for the design, development, manufacture, and service of assays, instrumentation, and in vitro diagnostic devices. 

To obtain the certification, the company said it implemented a quality-management system that meets standards for medical device and diagnostic manufacturing.

"Our implementation team worked diligently over the past six months to convert our existing quality system and procedures for ISO 13485:2003 compliance," Shannon Rodriguez, vice president of finance and administration at InDevR, said in a statement. "This certification serves to confirm that InDevR has the highest level of quality management through the life cycle of our products from design controls to customer service, thus ensuring the distribution of safe and effective products."

InDevR is in the final stages of developing FluChip-8G, a microarray-based clinical test for genotyping influenza viruses that is designed to help physicians rapidly distinguish between seasonal and potential pandemic non-seasonal influenza viruses. The company has said it expects to launch the product by the end of 2016.

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