Gemino certified according to ISO 13485

Gemino’s ISO 13485 compliance complements our ISO 17100 and ISO 9001 certification, ensuring optimized processes and the highest quality with regard to MDR/IVDR requirements.

Companies with medical technology products need to know that their multilingual content and translation processes comply with regulatory requirements. Gemino can ensure this thanks to its ISO 13485 certification.

Regulatory requirements are understood

Companies can rest assured that Gemino understands the MDR/IVDR requirements for labeling translations and takes them into account when designing and adapting processes.

Security & risk management

Our ISO 13485 certification confirms that, as a language service provider, we work according to standards that meet the requirements of medical device manufacturers for outsourced processes.

Gemino always takes a risk-based approach, especially when unexpected changes occur.

Simple verification

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

Thanks to our combination of ISO 17100, ISO 13485 and ISO 9001 certifications, we optimize your processes and provide the highest quality with regard to MDR/IVDR requirements.

Further information on our quality standards and especially about ISO 13485 can be found on our website.