BREL Medizintechnik Prüfung Zulassung DSC 0964

We assist with the validation of packaging, cleaning and sterilization, and more. We also produce technical documentation, including software documentation in accordance with IEC 62304 up to Class C, in accordance with the new Medical Device Regulation (MDR) and with FDA and other country-specific regulations. We will gladly support you with local registration of your device.