hemotune AG Expands ISO 13485 Certification

Schlieren-based medical device company Hemotune AG has received dual certification for its blood purification process. According to a press release, the company has received 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 design 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 effectiveness. It was released in March 2016.

ISO 13485:2016 is the gold standard for medical device quality management systems, 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. Using a device similar to a dialysis machine, it is possible to simultaneously remove various disease-relevant substances directly from the patient’s blood with maximum precision and efficiency. The first therapy was developed for the treatment of septic shock. Hemotune received the German Innovation Award in the Medical Technology category.

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