Haermonics is preparing for EN ISO certification
Haermonics is preparing for EN ISO certification for the design and development of systems to flush the thoracic body cavities. ISO 13485 is an International Quality System Standard for Medical Devices.
Commenting on the certification, the Chief Executive Officer of Haermonics says: “Receiving ISO certification is a major milestone in the company’s evolution and serves to distinguish us from other med-tech startup companies, who often think of this step in a later stage of the process. We value the quality aspect of the development process very much and therefore this felt like a natural step for us to take”.
Eva Diephuis, Product Owner en clinical trial coordinator, adds: “Even before we founded Haermonics we already thought of directly working according to the ISO13485 standards. It helps you doing the right thing and documenting every step you take in the development process. For us as a start-up company it is a great way to accelerate our process of delivering the highest quality possible. In the end this quality driven approach will contribute to the CE-marking process of the Haermonics Flush device.