MEDICAL TRANSLATION
Medical translation services for pharma, clinical trials & healthcare
ISO 17100 certified medical translation services trusted by global pharma companies, clinical research organizations, and medical device manufacturers. Native linguists with medical background, EMA-ready regulatory workflows, and GDPR-compliant secure delivery across 11+ languages.
ISO 17100 · GDPR · EMA-ready · 11+ languages · native medical linguists
OVERVIEW
Medical translation services trusted by pharma and healthcare leaders
Medical translation is not general translation. A misused term in a patient information leaflet can delay approval — or worse. Our medical translation services combine ISO 17100 certified processes with native linguists who hold medical or life-sciences backgrounds, working across pharma, clinical research, and medical device sectors.
Every project runs through EMA-ready workflows with two-linguist QA, terminology management, and regulatory-compliant delivery. We handle clinical trial documents, patient information leaflets (PIL), summary of product characteristics (SmPC), informed consent forms, medical device IFUs, and pharmacovigilance content across 11+ languages.
GDPR compliance is built into every delivery. Secure file transfer, restricted access, and audit-tracked workflows protect patient data and confidential trial information. Our medical translation services meet the compliance standards of European Medicines Agency (EMA), FDA, and MDR/IVDR frameworks.
Whether you’re preparing a market authorization submission, translating a clinical trial protocol, or localizing a medical device manual — our medical translation services scale from single documents to full regulatory packages, with fixed-scope quotes returned within 24 hours.
EDUCATIONAL
What actually happens during professional medical translation?
Medical translation isn’t dropping text into a translation tool. Every project follows an ISO 17100-certified workflow with two-linguist review, terminology validation, and regulatory-grade delivery.
01
Brief & Terminology Setup
We prepare terminology database using MedDRA, EDQM Standard Terms, and your company-specific glossaries.
02
Certified Medical Translation
Native linguists with medical or life-sciences backgrounds translate the source content with verified subject-matter expertise.
03
Independent Medical Review
A second independent linguist reviews the translation for accuracy, terminology consistency, and regulatory compliance.
04
Regulatory Formatting
Documents formatted per EMA QRD templates, EU MDR format, and ISO 15223-1 symbols — ready for direct regulatory submission.
05
Certified Delivery + Archive
Final files delivered via secure encrypted transfer with translation certificate. All documentation archived per ISO 17100 requirements.
WHAT WE OFFER
Every type of medical translation, under one roof
Our medical translation services cover every regulated document type from clinical trials to medical devices to pharmacovigilance content.
Clinical Trial Documentation
Protocols, informed consent forms, case report forms, investigator brochures, and patient-facing materials translated to ICH-GCP standards for global multi-centre trials.
Regulatory & Marketing Authorization
Full submission packages for EMA, FDA, MHRA, and national authorities. QRD template compliance, EDQM terminology, and dossier-ready formatting.
Medical Device Documentation
IFUs, labels, packaging, technical files, and clinical evaluation reports translated per EU MDR 2017/745 and IVDR 2017/746 requirements.
Patient Information Leaflets
SmPC (Summary of Product Characteristics), PIL (Patient Information Leaflet), and package inserts localized with regulatory-ready readability testing.
Pharmacovigilance Content
PSUR, DSUR, safety reports, ICSRs, and risk management plans translated by pharmacovigilance-experienced linguists with strict confidentiality.
Medical Marketing & Publications
Scientific journals, medical education materials, congress presentations, and healthcare marketing content adapted for HCP and patient audiences.
KNOW THE DIFFERENCE
Medical translation compared: Digi Media vs Alternatives
Not all translation providers deliver regulatory-grade medical content. Here’s how our medical translation services stack up against machine translation and generic agencies.
| Criteria | Machine Translation | Generic Agency | Digi Media |
|---|---|---|---|
| Linguist Qualifications | AI / no human review | General translators | Native + medical/life-sciences background |
| ISO 17100 Certification | Not applicable | Not always certified | ISO 17100 certified process |
| Regulatory Compliance | No compliance | Generic quality control | EMA, FDA, MDR, IVDR-ready |
| Terminology Management | Inconsistent terms | Basic glossary use | MedDRA, EDQM Standard Terms |
| Two-Linguist Review | None | Optional add-on | Standard on every project |
| GDPR & Data Security | Data used to train AI | Basic NDA | GDPR compliant · encrypted transfer |
| Certified Translations | Not available | Extra cost | Available on request · included when needed |
| Turnaround Time | Instant · unreliable | 5-10 days · variable | 3-7 days · guaranteed |
| Regulatory Risk | High · rejection likely | Medium · terminology errors | Low · submission-ready output |
DECISION SUPPORT
Is professional medical translation right for your project?
A quick self-check to confirm our medical translation services are the right fit for your regulatory, clinical, or medical marketing needs.
✓ This service is right for you if
- You need translations for regulatory submissions (EMA, FDA, MHRA)
- Your project involves clinical trials, medical devices, or pharmacovigilance
- Patient safety depends on accurate terminology and readability
- ISO 17100 certified process is required by your quality standards
- GDPR-compliant handling of clinical or patient data is essential
- You need certified translations for regulatory or legal purposes
🏥 Typical projects we handle
- Clinical trial protocols, informed consent forms, and CRFs
- EMA marketing authorization dossiers and QRD-compliant PILs
- ical device IFUs, labels, and technical files (MDR/IVDR)
- Pharmacovigilance reports (PSUR, DSUR, ICSR translations)
- Patient recruitment materials and clinical trial websites
- Medical journals, HCP education, and scientific publications
Not sure if our medical translation services fit your project? Send us your documents and target markets — we’ll return a scoped translation plan with fixed quote and delivery timeline within 24 hours.
WHO WE HELP
Trusted by pharma, biotech, and medical device leaders worldwide
From global pharma companies to specialized medical publishers — our medical translation services serve every organization that requires regulatory-grade multilingual content.
Pharmaceutical Companies
Global pharma companies producing regulatory submissions, patient information materials, product labelling, and pharmacovigilance content across EU and international markets.
Biotech & Life Sciences
Biotech startups and life-sciences firms translating clinical trial documentation, gene therapy protocols, and orphan drug submissions for regulatory approval.
Medical Device Manufacturers
MedTech companies translating IFUs, packaging labels, technical documentation, and clinical evaluation reports per EU MDR and IVDR requirements.
Clinical Research Organizations
CROs managing multi-country trials with informed consent, patient recruitment materials, investigator brochures, and study documentation across 11+ languages.
Regulatory Consultants
Regulatory affairs consultancies preparing MAA, IND, and CE marking submissions with QRD-compliant translations and dossier-ready formatting.
Hospitals & Healthcare Systems
Hospitals and healthcare providers translating patient education materials, informed consent forms, discharge instructions, and multilingual patient communications.
Medical Publishing
Medical journals, HCP education platforms, and scientific publishers translating peer-reviewed articles, medical textbooks, and continuing medical education content.
Digital Health & MedTech
Public health authorities and government agencies translating public health campaigns, vaccination materials, epidemiological reports, and multilingual health communications.
Government Health Agencies
Public health authorities and government agencies translating public health campaigns, vaccination materials, epidemiological reports, and multilingual health communications.
WHY US
ISO 17100 certified, EMA-ready, two-linguist review as standard
Our medical translation services combine ISO 17100 certified processes, native linguists with medical backgrounds, and regulatory-compliant delivery for pharma, biotech, and medical device companies worldwide.
11+
Languages
ISO 17100
certified translation process
2-Linguist
review as standard on every project
GDPR
GDPR
Every medical translation runs through ISO 17100 certified workflows with native linguists who hold medical or life-sciences backgrounds. Our medical translation services use MedDRA and EDQM Standard Terms for consistent regulatory terminology, deliver EMA-ready submissions, and meet the compliance standards of European and international health authorities. Trusted by pharma companies, CROs, medical device manufacturers, and healthcare systems across Europe.
LANGUAGES
Medical translation in 11+ languages, worldwide
Our medical translation services deliver regulatory-grade content in every major European, Nordic, and Baltic language — with native linguists holding medical or life-sciences backgrounds.
GB
English
🇬🇧
RU
Russian
RU
DE
German
🇩🇪
FR
French
🇫🇷
EE
Estonian
🇪🇪
LT
Lithuanian
🇱🇹
LV
Latvian
🇱🇻
PL
Polish
🇵🇱
FI
Finnish
🇫🇮
SE
Swedish
🇸🇪
NO
Norwegian
🇳🇴
SEE IT IN ACTION
Every regulated document type we translate
From clinical trial protocols to pharmacovigilance reports our medical translation services cover every document type required for regulatory submissions.
Pharma, biotech, and medical devices — trusted by global leaders
Our medical translation services deliver regulatory-grade content for pharmaceutical companies, biotech firms, medical device manufacturers, and CROs across Europe and worldwide. Every project runs through ISO 17100 certified workflows with GDPR-compliant secure delivery.
CREDENTIALS
Certified for enterprise-grade medical translation
Every project meets the highest global standards for translation quality, regulatory compliance, data protection, and clinical research integrity.
EMA-Ready
European Medicines Agency compliant
ISO 17100 Certified
Translation quality standard
ICH-GCP Compliant
Clinical trial standards
GDPR Compliant
EU data protection
FAQ
Medical translation frequently asked questions
Everything pharma, biotech, and medical device teams need to know about our medical translation services.
What are professional medical translation services?
Medical translation services translate regulated content — clinical trial protocols, patient information leaflets, medical device documentation, and regulatory submissions — using ISO 17100 certified processes and linguists with medical or life-sciences backgrounds. Every project meets pharma industry accuracy standards.
Why is medical translation different from general translation?
Medical translation requires specialized terminology (MedDRA, EDQM Standard Terms), regulatory compliance (EMA, FDA, MDR), and two-linguist review as standard. A general translator can’t safely handle a clinical trial protocol or drug leaflet — the risks to patient safety and regulatory rejection are too high.
Are your translators qualified in medicine?
Yes. All medical linguists on our team hold verified backgrounds in medicine, pharmacy, life sciences, or specialized therapeutic areas. We assign translators by domain — cardiology, oncology, medical devices, pharmacovigilance — matching your specific project needs.
Do you handle EMA regulatory submissions?
Yes — EMA-ready is our default. We use QRD templates, EDQM Standard Terms, and EMA product information conventions. Our workflows are designed for MAA dossiers, variations, renewals, and other regulatory filings across EU centralized and national procedures.
How do you ensure medical terminology accuracy?
Every project uses MedDRA (medical dictionary for regulatory activities), EDQM Standard Terms for dosage forms, and your company-specific terminology database. Two-linguist review with independent medical reviewer catches any terminology inconsistencies before delivery.
What about GDPR and patient data?
All medical translations run through GDPR-compliant workflows with encrypted file transfer, restricted access, audit-tracked handling, and secure archival. We sign NDAs and BAAs, and we do not use patient data or trial content for translation memory training.
Do you provide certified translations?
Yes — certified translations available on request. We provide translation certificates with translator credentials, ISO 17100 compliance statements, and notarized certifications when needed for regulatory or legal purposes. Standard in most EU jurisdictions.
What languages do you cover for medical work?
11+ core languages including English, Russian, German, French, Estonian, Lithuanian, Latvian, Polish, Finnish, Swedish, and Norwegian. Plus 20+ additional languages on request — Spanish, Italian, Portuguese, Dutch, Czech, Hungarian, and more — all with medical-background linguists.
How long does medical translation take?
Standard delivery is 3-7 business days for typical documents (PIL, SmPC, patient consent forms). Large regulatory dossiers (MAA submissions, technical files) run 2-4 weeks depending on volume. Rush service available for time-critical filings.
What file formats do you deliver?
Any regulatory or business format — Word (DOCX), PDF, InDesign (IDML), XLIFF, XML, and structured content formats. We can work directly with your DTP or regulatory team’s format requirements including EMA XML-based dossier structures.
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START YOUR PROJECT
Ready to send your medical documents for translation?
Send us your brief — document types, target languages, regulatory framework (EMA, FDA, MDR), and delivery deadline. We'll return a full translation plan with fixed quote and turnaround time within 24 hours, wherever you are in the world.
✓ 24-hour quote · ✓ ISO 17100 certified · ✓ GDPR compliant · ✓ EMA-ready · ✓ 11+ languages · ✓ 2-linguist review