IMDx has announced that they have received ISO certification to design, develop, and manufacture in vitro diagnostic devices for the diagnosis of infectious diseases in molecular biology, and will obtain licenses to commercialize the tests in Canada.
Under the Canadian Medical Devices Conformity Assessment System, 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, pre-audit, 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.
“Receiving this certification is a true testament to our dedication to making high quality products,” says Dr. Alice Jacobs, MD, Chairman & CEO.
Dr. Jacobs continued, “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.”
The IMDx portfolio of infectious disease diagnostics includes CE-marked tests for toxigenic Clostridium difficile, vancomycin-resistant enterococci, and Group B streptococcus.
The IMDx pipeline includes assays for detection of Herpes Simplex Virus 1 and 2, Influenza A/B and RSV, Epstein-Barr virus, BK virus, and additional assays focusing on oncology, human genetics and companion diagnostics.