On August 3, 2017, Exosome Diagnostics, Inc., a leader in the liquid biopsy market, announced that it has received ISO 13485 certification for both its USA and Germany facilities. This achievement paves the way for the company to be an In Vitro Diagnostic (IVD) medical device design and manufacturing organization. Combined with the company’s CLIA-certified Waltham, Massachusetts laboratory and ISO 15189-accredited Munich laboratory, the IVD-certified locations will serve as an integral part of the company’s strategy for the instrument platform, companion diagnostics, and diagnostics to better the lives of patients worldwide. The British Standards Institution (BSI) has certified Exosome Diagnostics under ISO 13485:2003 under CMDCAS for the following scope: “Design, development, manufacture, distribution, installation, and service of In Vitro Diagnostic (IVD) medical devices including opto-electromechanical instruments, sample collection kits, reagents, and disposables.” As defined by the International Organization for Standardization, ISO 13485 is a standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices (IVDs) and related services that consistently meet customer needs and applicable regulatory requirements. “This ISO 13485 certification is a testament to the compliance initiatives undertaken by Exosome Dx to design and manufacture IVDs. Working closely with the notified body and appropriate regulatory agencies, Exosome Dx adheres to the strictest standards to provide the highest quality of products to clinicians,” stated Raaj Venkatesan, Head of Regulatory Affairs at Exosome Diagnostics.
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