Gemino plans ISO 13485 certification for Q1 2023

As more and more of our clients belong to the life science industry, we are well aware of the basic requirements of ISO 13485 and know which of these requirements apply to our processes and services.

ISO 13485 certification is therefore the next logical step. This certification will ensure that the provisions of ISO 13485 are a verified and integral component of our services – in addition to the ISO 9001 and ISO 17100 certification we already hold.

Our clients from the medical technology sector will thus be assured that all translation processes in the field of labeling are carried out in conformity with ISO 13485. Potential risks will be adequately assessed and managed at all times. This is especially important if Gemino is classified as a critical supplier by a manufacturer’s notified body.

The ISO 13485 standard defines the framework for quality management in conformity with the current EU Medical Devices Regulation (MDR) as well as the In Vitro Diagnostics Regulation (IVDR).

We are currently in the preparatory phase. ISO 13485 certification is planned for the first quarter of 2023.