IMDx Receives Certification to Develop, Manufacture IVD Devices

IMDx underwent a stringent audit of its quality system to ISO 13485:2003 with the implementation of requirements from the Canadian Medical Devices Regulations. The audit included quality management system development, documentation review, preaudit, initial assessment, and clearance. The ISO 13485:2003 accreditation was received from the Laboratoire national de métrologie et d’essais (LNE/G-MED) and is accepted worldwide as the inclusive international standard that defines quality in the area of medical devices.

The IMDx portfolio of infectious disease diagnostics includes CE-marked tests for toxigenic Clostridium difficile, vancomycin-resistant enterococci, and Group B Streptococcus.

“Receiving this certification is a true testament to our dedication to making high quality products,” says Dr. Alice Jacobs, MD, chairman and CEO of IMDx. “Our mission at IMDx is to make a wide range of diagnostic tests available as broadly as possible. The ability to eventually commercialize our tests in Canada brings us closer to achieving the goal of improving healthcare worldwide.”

Related Links:
International Organization for Standardization
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