InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced today that they received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices.
InDevR achieved ISO 13485:2003 certification following a successful audit of its quality management system and organizational structure by Intertek, a global leader in providing companies services to ensure the quality and safety of their products, processes and systems.
The certification covers the design, development, manufacture and service of assays, instrumentation, and in vitrodiagnostic devices, demonstrating that InDevR has effectively implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing. Shannon Rodriguez, Vice President of Finance and Administration, stated, “Our implementation team worked diligently over the past 6 months to convert our existing quality system and procedures for ISO 13485:2003 compliance. 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.”
The FluChip-8G IVD product in development at InDevR is a multiplexed influenza diagnostic that will enable physicians to identify seasonal influenza viruses and distinguish them from novel potentially pandemic influenza viruses. The FluChip-8G product is funded through a contract (HHSO100201400010C) with the Biomedical Advanced Research and Development Authority (BARDA).