Sector
- ISO 17100 certification · 2016
- 25+ years in language services
We translate clinical studies, instructions for use (IFU), medical reports and regulatory dossiers using specialist medical translators, under an ISO 17100 workflow, with rigorous terminology management and contractual confidentiality for health data.
- Scope
- Clinical studies and protocols
- IFUs and medical-device labelling
- Regulatory dossiers and correspondence with authorities
- Credentials
- ISO 17100:2015 · ISO 18587:2017 · ISO 29993 · TÜV Hellas
- On every project
- A confidentiality agreement before any engagement begins.
- Numbers, units and dosages are never silently converted.
- Every ambiguity in the source comes back as a question rather than being resolved by us.
- Back-translation available on request, as a separate step.
- Response
- An itemised quote within one working day, with a firm delivery date.
- ISO 17100 certification · 2016
- First in Greece
- Athens Chamber of Tradesmen · 2018 (on the Athens Chamber site, in Greek) (opens in a new tab)
- Entrepreneurship award
- Official supplier
- NATO
- years in language services
- 25+
- 271 client reviews
- 4.9/5 on Google
How we work
How a project runs, step by step.
In medical and pharmaceutical work an error can change a dose or an instruction. The process rests on subject-matter expertise and on a second professional who checks every number and dosage against the source.
- 01Matched to a specialist
Assigned to a translator with demonstrable experience in that specific field. The work does not move to another specialism because someone is available.
- 02Aligned to your approved terminology
If you hold approved templates or a glossary, they override our own preferences.
- 03Translation
Units, dosages and abbreviations carry across unconverted unless you explicitly ask otherwise.
- 04Independent revision
A second professional verifies completeness and every numerical value against the source.
- 05Flagged, not decided
Where wording touches a regulatory claim, we ask you. You give the approval.
Independent revision by a second professional is an ISO 17100 requirement.
Scope
What we translate
- Clinical studies and protocols
- IFUs and medical-device labelling
- Regulatory dossiers and correspondence with authorities
- Medical reports and patient records
- Scientific articles and literature
Capabilities
Why EL-Translations.
Terminology in depth
Specialist knowledge and continuing training in biomedical terminology, to the point that we also teach it at EL-Academy.
Consistency across multi-year programmes
Per-client, per-product memories and term bases keep every dossier version consistent with the last, a key regulatory requirement.
Sensitive data, strict handling
Contractual confidentiality, minimised access and a strict internal policy, before any material changes hands.
Terminology sample
Sector terminology
Your sector’s language, in both languages.
A sample of the terms checked on every project, against your own glossary and the sector’s reference sources.
- Περίληψη Χαρακτηριστικών του Προϊόντος, in English: Summary of Product CharacteristicsReference: SmPC
- Φύλλο οδηγιών χρήσης, in English: Package leafletReference: PL
- Δραστική ουσία, in English: Active substanceReference: SmPC 2
- Αντενδείξεις, in English: ContraindicationsReference: SmPC 4.3
- Ανεπιθύμητη ενέργεια, in English: Adverse reactionReference: Pharmacovigilance
- Έντυπο συγκατάθεσης κατόπιν ενημέρωσης, in English: Informed consent formReference: ICF
An illustrative sample. On every project, terminology follows your approved glossary first.
Revision sample
Revision under ISO 17100
A second check, sentence by sentence.
Every translation is checked by a second translator, sentence by sentence, against the source. The reviser’s corrections are shown below.
Η θεραπεία πρέπει να διακόπτεται εάν εμφανιστεί εξάνθημα.
The therapy must be interrupted if a rash appears. → Treatment must be discontinued if a rash appears.
- 1«Treatment»: the term used in approved English medicinal product texts, not a literal rendering of «θεραπεία».
- 2«discontinued»: the stop here is permanent. «interrupted» means a temporary pause, which is a different clinical instruction.
An illustrative example of the method, not client text.
Contents
Regulatory compliance in medical translation
Medical translation operates inside strict regulatory frameworks: the European Medicines Agency (EMA), the Medical Device Regulation (MDR), FDA guidance, GDPR for health data. Compliance is a precondition for a product's approval and circulation.
The scope covers clinical studies and protocols, informed-consent forms, patient information leaflets (PIL), SmPCs and regulatory documentation, pharmacovigilance and medical-device documentation: each project matched to its therapeutic area and target market.
Why an error here costs differently
A mistaken medical rendering can produce misleading dosage instructions, a wrong understanding of side effects, delays in approvals and serious regulatory consequences. Precision in medical terminology protects patients and companies.
That is why, on multicentre and multilingual clinical studies, we work with dedicated glossaries and terminology bases per therapeutic area: consistent terminology is fundamental to scientific credibility.
The medical and pharmaceutical texts we translate
The field is broad and every text has its own rules. On the pharmaceutical side we translate clinical trial protocols, informed consent forms, Summaries of Product Characteristics (SmPC), Patient Information Leaflets (PIL), pharmacovigilance reports and regulatory dossiers for the EMA and national authorities.
On the medical and medical-device side we cover diagnoses and patient histories, discharge summaries and test results, Instructions for Use (IFU) and technical documentation for medical devices, scientific papers and conference material. For each category we know the format, the terminology and the regulatory framework that governs it.
The patient and the specialist do not read the same text
A patient information leaflet needs plain, clear language that leaves no room to misread a dose or a side effect. A regulatory dossier for an authority needs rigorous scientific terminology. The same active substance speaks differently depending on who is reading, and the translation has to recognise that.
We match the tone to each document's audience without sacrificing accuracy. Where a study protocol requires it, we provide back-translation and linguistic validation, so the translated text is demonstrably equivalent to the original.
In which languages must device information be provided under the EU MDR?
Regulation (EU) 2017/745 on medical devices (MDR) provides that product information, such as instructions for use and labelling, is supplied in the languages of the member states where the device is made available. We translate it with strict terminology and independent revision. The exact obligation for each product and market should be confirmed by your regulatory affairs lead.
Three questions before any project.
Ask us and any other agency.
- 01What is the translator's experience in this specific therapeutic area?
- 02When the source is ambiguous, do you interpret it or return it?
- 03Can you supply a back-translation for our internal review?
Infrastructure & Reliability
Three ISO standards, audited by TÜV Hellas.
Enterprise-grade translation needs know-how, infrastructure and accountability. We have already built them, so you do not have to.
Next milestones: ISO 9001 (quality) & ISO 27001 (information security), certification in progress.
- Certified processISO 17100:2015 · ISO 18587:2017 · ISO 29993 · TÜV Hellas
- AI infrastructure with certified human controlNeural machine translation + ISO 18587 post-editing
- Secure portals for clients and vendorsSeparate, access-controlled environments per project and per translator
- Per-client translation memories & term basesTerminology consistency and lower cost over time
- Confidentiality & data security by defaultNDA before every engagement, strict data handling at every level
- A dedicated project manager on every project140+ languages · 25+ years · since 2001
For procurement
The supplier file, ready.
What a supplier evaluation usually asks for, available from day one.
- ISO 17100:2015Translation services: translator qualifications, independent revision, a documented workflow. · TÜV Hellas · valid until 16 February 2028PDF
- ISO 18587:2017Machine translation post-editing, carried out under our certified process. · TÜV Hellas · valid until 11 February 2027PDF
- ISO 29993Design, development and delivery of the EL-Academy programmes. · TÜV Hellas · valid until 21 February 2027PDF
- Company detailsEL-Translations ΙΚΕ · VAT and commercial register numbersPage
- Confidentiality policyHow we handle data and filesPage
Frequently asked questions
Before the first project.
Do you translate for regulatory submissions?
Yes: pharmaceutical and medical-device documentation with strict terminology and format control, independently revised on every deliverable.
How is patient data protected?
An NDA before every engagement, minimal access and strict internal handling: confidentiality is a contractual commitment.
No-obligation quote
Let's talk about your project
Describe your project or send us your material. You will receive an itemised quote within one working day, with a firm delivery date.
We reply within one working day.
ISO 17100 · ISO 18587 · ISO 29993 · Since 2001 · 140+ working languages