Specialist DTP
IFU & Labeling DTP
Instructions for Use, labeling and packaging typeset and localized to the regulatory format every market demands.
Why IFU and labeling DTP is high-stakes
Under frameworks such as EU MDR and IVDR, an IFU must appear in the official language(s) of every market where a device is sold, and labeling carries direct legal and safety weight. Formatting is part of compliance: symbol usage (ISO 15223-1), warning hierarchy and mandated structures must survive translation, and longer languages or RTL scripts must not break the layout.
What we handle
- Instructions for Use (IFU) and user manuals
- Device labeling, cartons and packaging artwork
- Pharmaceutical SmPCs, PILs and mock-ups
- Multi-market, multi-language rollouts from a single source layout
How B2K keeps it compliant
Each language version is rebuilt source-matched, preserving symbols, warnings and structure, then checked with read-free verification against the source and a four-stage QA. Output is delivered print- and web-ready, with accessible (PDF/UA-aware) files where required.
Request a free sample or pilot
Send us a sample document (or tell us the languages, formats and deadline) and we will scope the work, run a short pilot, and commit to a date we can hold.
Request a sample →Frequently asked questions
What is IFU DTP?
The specialist typesetting and localization of Instructions for Use documents so they remain compliant and legible in every market language, preserving symbols, warning hierarchy and mandated structure.
Do you handle labeling and packaging as well?
Yes - device labeling, cartons, packaging artwork, and pharmaceutical SmPCs and PILs, alongside IFUs.
Can you localize IFUs into all EU languages?
Yes; we produce source-matched IFU and labeling output across 40+ languages, including RTL scripts, suitable for multi-market EU MDR/IVDR rollouts.
How do you keep symbols and warnings intact after translation?
We rebuild each version source-matched and verify it element by element against the source, so symbols, warning hierarchy and structure are preserved.
Is the work done in-house?
Yes; B2K does not subcontract, and every file passes a four-stage QA before delivery.