Regulated markets offer little margin for error. Especially not when material is available in multiple languages. You must keep every publication, update, and detail change traceable, review it, correct it if needed, and transfer it to various systems. Companies require security through consistent and verifiable processes. Gemino provides you with this assurance. We identify the relevant questions and turn them into smart workflows.

This applies not only to medical technology: We handle the regulatory requirements for you

Which statement has been approved? Which version is valid? Which terminology is binding? What may be processed automatically? Which tools are validated? Where does which data flow? This is exactly where our workflow expertise becomes evident: We organize material according to function and risk, secure and document approvals, manage reviews, and ensure that approved material reaches its intended destination. These relationships are especially critical in medical technology.

Here, Gemino proves its expertise with certified quality management in accordance with ISO 13485 for translations in the field of medical devices. Clients from other industries also benefit from our expertise in managing regulatory requirements. Well-maintained translation memories, qualified translators, suitable TMS workflows, controlled use of MT and AI, and documented reviews are standard practice for us. After all, we actually like regulations.

Your data is subject to rules as well

With AI and MT, the age-old question is raised once again: Which material may be sent where? Customer data, unpublished product information, personal data, or confidential development documents may not just be sent to any old language model. Data protection, IT security requirements, confidentiality, and internal company policies always influence which technologies you can use in a translation process.

Gemino addresses these questions. Together with you, we review which content may be processed automatically, which systems are suitable for this, and where additional safeguards or alternative processes are necessary. For data exchange, Gemino offers its own secure file transfers, allowing even large volumes of data to be encrypted and transferred directly to Gemino servers. This enables you to use modern translation technology wherever it is appropriate and permitted.

This does not only apply to Life Science. In mechanical engineering, new EU regulations are changing how digital user manuals and multilingual product information are handled. The Digital Product Passport introduces additional structured and regulated product data into international content processes. At the same time, AI raises new questions about data processing and software use. We monitor these developments and incorporate them into the design of your workflows. This ensures you can take advantage of new opportunities without overlooking any requirements.