Hemotune receives double certification

(CONNECT) The Schlieren-based medtech company Hemotune AG has received double certification for its blood purification method. According to a statement, it was awarded ISO 13485:2016 certification for both sterile and non-sterile medical devices and nanoparticles for blood purification.

ISO 13485 is the internationally recognized standard for quality management systems in the development and manufacture of medical devices. The standard describes specific requirements to help companies ensure that their medical devices meet both customer and regulatory requirements for safety and efficacy. It was published in March 2016.

ISO 13485:2016 is the gold standard for quality management systems for medical devices, according to the Hemotune press release. Achieving this extension for sterile and non-sterile nanoparticles demonstrates the company's commitment to meeting the highest global standards.

Hemotune has developed the HemoSystem blood purification process. It is based on a nanostructured magnetic adsorber material. A device similar to a dialysis machine makes it possible to simultaneously remove various disease-relevant substances directly from the patient's blood with maximum precision and efficiency, the system is described by the German Innovation Award. The first therapy was designed for the treatment of septic shock. Hemotune received the German Innovation Award in the Medical Technologies category in 2022.

Hemotune is a spin-off from the Swiss Federal Institute of Technology in Zurich (ETH) from 2017 and is based in the Bio-Technopark Schlieren-Zurich. ce/gba