Press release
mivenion receives ISO 13485 certification for Xiralite® manufacturing and distribution
mivenion has received the official ISO 13485:2003 + AC:2009 certification as a medical device manufacturer. Published in 2003, the ISO 13485 standard outlines the requirements for a comprehensive quality management system for all aspects of the design and manufacturing process for medical devices. The certification covers the design, development, manufacturing, and distribution of the patented Xiralite® fluorescence camera system and its XiraView® software.“We are delighted that we can announce this important milestone for mivenion. This further improves our solid basis for continuous growth of the installed system base on the basis of proven quality standards”, states Michael Schirner, managing director and responsible for manufacturing of the fluorescence camera system Xiralite®. “The achievement demonstrates mivenions’ commitment to consistently meet customer and regulatory requirements for future expansion in Germany and markets beyond. The ISO 13485 compliant quality management system we now have in place adheres to the most widely recognized international standard and will surely foster our commitment to offering our leading technology to international customers.”
Xiralite® in combination with the diagnostic dye ICG is the first dedicated solution for the Rheumascan procedure to diagnose inflammatory joint disorders in the hands. Xiralite® induces the fluorescence of ICG using light-emitting diodes (LED) and quantitatively records the fluorescence emitted in all joints of both hands. Thus active inflammation can be simultaneously diagnosed in more than 30 joints of both hands. The software XiraView® manages the data acquisition process and assists in the image analysis by trained physicians.
mivenion GmbH is a life-science company focusing on personalized medicine for patients with inflammatory and autoimmune diseases. With its strong expertise in both pharmaceuticals and medical devices, mivenion is providing cutting edge solutions for life-long patient care. A compelling network of academia and industry partners is supporting mivenion in achieving its goals. Broad patent applications are the foundation of mivenion’s proprietary position. mivenion’s drug development candidates comprise both diagnostic and therapeutic properties and are perfectly suited for optimizing each individual treatment case. mivenion’s medical solutions encompass innovative diagnostic imaging and provide evidence on treatment outcome. Xiralite, the leading product of mivenion, enables the Rheumascan procedure. It for the first time provides an integrated solution for patients with inflammatory diseases in the hands. Based on optical technologies, active inflammation is diagnosed at a very early stage with confidence, attractive technical ease, and high patient comfort.
Dr. Michael Schirner
mivenion GmbH
Robert-Koch-Platz 4
10115 Berlin
Germany
Phone +49 30 68837920
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