Humedics Receives ISO 13485 Certification
News Aug 11, 2015
Humedics GmbH has announced that the company has been certified according to DIN EN ISO 13485. The Quality Management System of the company covers the entire spectrum of processes from design and development, via manufacturing to distribution of its FLIP devices for liver function analysis and corresponding breathing masks. With this certification an important pre-condition for the European marketing of the LiMAx test has been achieved.
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.