Schlieren, Switzerland, August 24th 2023 – hemotune AG, a pioneering MedTech startup revolutionizing blood purification with cutting-edge nanotechnology, proudly announces its attainment of ISO 13485 certification. The certification covers design and development, production, distribution, and service of medical devices for blood purification including coated colloidal nanoparticles and marks a significant milestone towards delivering its innovative blood purification technology to patients.
Schlieren (Switzerland), 23rd March 2023 – hemotune AG, the Schlieren-based MedTech company known for its magnetic blood purification platform announces a joint feasibility project with the global pharmaceutical company AstraZeneca.
The new Regulations for medical devices and in vitro diagnostic devices create a more robust, transparent, and sustainable regulatory framework. In this article, we will tell you all you need to know to be up to date to the new requirements implemented by the European Commission.
Increasing patients’ safety and care in research is vital when preparing and conducting your study. From a HEMEX perspective, we are tackling in this article four important points you should consider during the process.
Market tracking is not only exciting but has recently become a requirement under the Medical Device regulations (MDR) of the EU. Join us in learning what steps are necessary to complete the post-market clinical follow-up!