Humedics receives ISO 13485 certification
Milestone for market entry of LiMAx test for liver function diagnostics
Humedics has established a Quality Management System (QMS) according to DIN EN ISO 13485 that covers all processes from design and development, via manufacturing to distribution. The QMS secures a consistently high quality and safety of the FLIP 2.0 analysis device and the corresponding breathing masks. At the same time the certified QMS is a pre-condition for the CE mark of the devices and demonstrates compliance with regulatory requirements. The certification audit was performed by Hamburg-based MEDCERT GmbH.
Erwin de Buijzer, CEO of Humedics GmbH, stated: “After the optimization of our FLIP devices for industrial scale production the ISO certification is an important milestone for the successful market entry of our innovative LiMAx test for liver function diagnostics.” The LiMAx test, together with the corresponding FLIP device and the diagnostic drug offers a clinically proven significant added value for patients with liver diseases and liver surgery.
Based in Berlin, Germany, Humedics GmbH is specialised in rapid and accurate liver function measurement using LiMAx®, an innovative technology for analysing exhaled air. The LiMAx® test provides physicians with a method for quantitatively assessing an individual patient’s liver function capacity within minutes. This enables physicians to select treatment strategies and follow disease progression based on up-to-date knowledge of the functional health of the liver.
Current applications, which have already been published in prestigious medical journals, include liver function diagnosis before and after liver transplantation, surgical planning for liver surgery (such as assessing how much liver tissue can be removed without increasing the risk of acute liver failure), and assessment of liver diseases such as fibrosis and cirrhosis. At present, more than 20 studies regarding new indications are being conducted. These include diagnosing and staging of chronic liver diseases such as non-alcoholic steatohepatitis (NASH), as well as selecting, monitoring and managing different oncology treatment options.
These studies, initiated by researchers, have already provided evidence of further potential for the LiMAx® tests. The LiMAx® test is in routine clinical use at more than 30 leading university hospitals in Europe. So far, more than 20,000 LiMAx® tests have been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.