Medical device translation
Translate the information that accompanies your device
Translate medical device instructions, labels and technical documents with terminology and layout managed across the set. Send us your files, target markets and deadline for a quotation.
We work with your approved source and terminology; a linguist project manager coordinates the workflow and checks the finished files.
Documents we translate
Medical device projects can involve several documents, formats and reviewers. We can help with instructions for use, including electronic instructions; labels and packaging text; declarations of conformity and technical documentation; clinical investigation materials; and training or support content.
If the same terminology appears across several documents, we can plan them as a set. That makes it easier to manage approved wording and changes to the source.
Terminology, warnings and artwork
Device names, intended use, warnings and contraindications need careful handling. We work with the reference material you provide, including approved terminology, previous translations and product-specific instructions. Questions can be referred back to your team as the work progresses.
Labels and instructions also have practical constraints. Text may expand in translation, while symbols, identifiers and artwork need to remain in place. Tell us about the intended format and layout requirements so we can agree what the project includes.
Translation requirements by market
Language requirements for device information depend on the applicable rules and the markets where the device is made available. The European Commission publishes country-specific information for the MDR and IVDR. Share your target-market list and your own regulatory requirements when requesting a quote; your regulatory team remains responsible for confirming the applicable rules.
Quality and project management
Your project manager coordinates the assignment and the handoff between stages. We agree the translation and review route for each project, taking the document's purpose and your requirements into account.
Transferendum holds ISO 9001, ISO 17100 and ISO 18587 certification. Where you need a particular standard or production route to apply, tell us when requesting your quote so we can confirm the scope.
An instructions-for-use update can affect labels, patient information and multiple language versions. A project brief that identifies the approved master, target markets and the point at which artwork is frozen helps us plan those dependencies with your team.
Questions
Can you translate instructions for use and labels?
Yes. Send us the files, target languages and any terminology or layout requirements. We will confirm the scope and available formats in our quote.
Can you work to a notified-body or launch deadline?
We confirm the schedule after reviewing the documents, languages, formats and deadline. Include intermediate review or artwork dates in your brief.
Will the translation be accepted by a notified body?
We can agree a translation and review process for your documentation. The relevant authority or notified body makes its own assessment and decision.
Discuss your device documentation
Tell us about your device, document set, target languages and delivery date. We will discuss the scope and provide a quotation.