The efforts of the last years have been worthwhile: In January we have successfully passed stage 1-audit of the Medical Device Regulation 2017/745 (MDR), recently followed by stage 2, also with a successful result.
Thus, we have reached the status “MDR-Ready” and now wait for the approval of our technical file for class Ir-products until end of April. We will keep you updated as soon as the new Certificates are available!