Successful completion of ISO 13485 surveillance audit

We are delighted to announce that our ISO 13485 certification was confirmed by a surveillance audit last week.

Why implement ISO 13485 in the field of translation?

Companies with products in the medical technology sector must ensure their multilingual content and translation processes meet regulatory requirements. Gemino’s ISO 13485 certification provides this assurance.

With ISO 13485, our clients can be sure that Gemino is familiar with the MDR/IVDR requirements for translations in the field of labeling, and that they are taken into account when designing and adapting processes.

Even if the notified body does not require language service providers to comply with ISO 13485 (yet): With Gemino as a certified language service provider, compliance with obligations for managing and monitoring outsourced translation processes can be quickly and easily verified.

Further information about our quality standards and especially about ISO 13485