Specialist translation for pharma & medtech Medical translation for MDR compliance and fast approvals.
Audit-ready medical specialist translation for authorisation dossiers, clinical trials and instructions for use (IFUs). Terminology that follows the applicable standards, and data security under ISO 27001 with servers in Germany.
Four ISO certifications (including ISO 27001)Translation partner to companies with high standards
- Compliance: we deliver translations to ISO 17100 for medical documents such as IFUs and EMA QRD templates.
- Security: servers in Germany keep the processing of patient data from clinical trials compliant with the GDPR.
- Terminology: 8-digit MedDRA codes integrated to the standard for pharmacovigilance.
- Delivery times: standard projects from five working days. For urgent approval projects we offer an express service.
How we keep your approvals compliant
Time to market and lower risk under the MDR and IVDR
With the Medical Device Regulation (EU MDR) and the mandatory EUDAMED rollout, the European Union has tightened the language requirements sharply. Regulators now treat the translation of medical content as an integral part of risk reduction rather than an administrative afterthought.
Delays in the approval process caused by faulty document workflows carry a heavy opportunity cost. tolingo acts as your strategic integrator: structured processes, InDesign-to-XML workflows and validated terminology management shorten your approval cycles and protect your time to market in a form the authorities accept.
What a mistranslation actually costs
FDA data shows that up to 19% of all drug recalls and almost 50% of software-related medical device recalls trace back to errors in labelling, in the user interface or in the localisation. Classic false friends, non-cemented in place of non-modular cemented for example, put market approval and patient safety at risk alike.
Critical medical documents
From the clinical trial to the EMA dossier
Requirements differ sharply between communication aimed at patients and communication aimed at professionals. We staff your project with subject matter experts who know the specific regulatory context your document sits in.
Strict compliance with the QRD conventions for summaries of product characteristics (SmPCs) and package leaflets.
Translation of study protocols and informed consent forms, with certified back-translation included.
Instructions for use and implant cards with terminology to the standard, for professionals and for lay readers (InDesign/XML).
Summaries of safety and clinical performance. We make sure the patient versions are easy to read.
Localisation of medical apps and device software (GUIs), with code variables protected so nothing crashes.
Medical specialist translation for day-to-day hospital work, scientific publications and medical expert opinions.
Standards and requirements at a glance
Data-driven localisation for export markets
The requirements for clinical documentation vary a great deal by target market, the FDA in the United States compared with the EMA in Europe for example. Our processes mirror those specific regulatory conditions.
| Document type | Relevant standard / authority | Language requirement / workflow note |
|---|---|---|
| Instructions for use (IFUs) | EU MDR / IVDR | The professional register and the lay register have to be kept apart. Often an InDesign-to-XML workflow. |
| Package leaflets & SmPCs | EMA (QRD templates) | Strict compliance with the QRD conventions. Migration to ePI (electronic product information) via FHIR XML. |
| Informed consent forms (ICFs) | FDA Part 50 / ICH E6 | Requires back-translation and cognitive debriefing with lay readers. |
Language pairs for global approval markets
The most frequent pairs in pharma and medtech
Pharmaceutical and medical device approvals follow the language requirements of the target market. All 24 official EU languages are in scope for the EU, and trial sites in the United States and Asia add further mandatory languages.
| Language pair | Approval market | Where it is used |
|---|---|---|
| German to English | FDA (USA), MHRA (UK), global | CTD modules, study protocols, FDA submissions |
| German to French | ANSM (France), Belgium, Switzerland | IFUs, ICFs, EMA QRD templates |
| German to Spanish | AEMPS (Spain), Latin America | Multi-country trials, pharmacovigilance |
| German to Chinese | NMPA (China) | CDE submissions, simplified characters, GB standards |
| English into 24 EU languages | EMA (centralised procedure) | Package leaflets, SmPCs, EUDAMED entries |
Medical glossary
Keeping terminology under control
In a regulatory context a translator cannot swap a term such as “headache” for a synonym. To keep your dossiers consistent, we work with established databases and standards:
- MedDRA code
- The Medical Dictionary for Regulatory Activities. Every term, gastric haemorrhage for example, carries an 8-digit numeric code that stays identical across languages. We integrate that nomenclature natively in our tools.
- Back-translation
- A validation step in which an independent linguist translates a finished study document, an ICF for example, blind back into the source language, so that any drift in content is visible to the ethics committee.
- ePI & HL7 FHIR
- The electronic product information (ePI) from the EMA is based on FHIR XML. We move your conventional documents straight into that machine-readable, structured format.
- EDQM Standard Terms
- An authoritative database from the Council of Europe that defines exactly how pharmaceutical dosage forms and routes of administration must be named in 35 languages.
Prices and translation methods
Keeping cost under control on large dossiers
Sensitive health data and approval documents get our closest attention. For patient-facing information we work mainly with human specialist translators, followed by a check under the four-eyes principle. For large volumes of internal research data or literature screening we offer post-editing (MTPE) under ISO 18587 from €0.05/word. Your translation memory brings the cost of follow-up projects down further.
Please note: our translations are not a substitute for medical or regulatory advice. Sign-off of your documents with the authorities (EMA, FDA) remains the responsibility of your own regulatory affairs team.
Common questions (FAQ)
Data protection, validation and quality management
Certified security for your global market access.
Keep regulatory risk down with translation workflows that meet the standards. Talk to our healthcare specialists about your next EMA or FDA submission.
Certified to ISO 17100 and ISO 27001 · Certificate of accuracy included