Medical Translation Services
One partner for your entire medical and life sciences language program — accurate, compliant, and accountable. The Translation Company is a women-owned (WBENC-certified) US firm that has translated medical and life sciences content since 2005, for hospitals, clinical research organizations, universities, pharmaceutical companies, and medical device manufacturers. We pair modern, governed technology with qualified human expertise, because in medical translation a wrong word is not a typo — it is a clinical and regulatory liability.
Operating to ISO 9001 and ISO 17100 standards · Women-owned (WBENC) · Serving regulated teams since 2005
Last updated June 2026.
Book a consultation with our CEO, Camila Saunier — a working session about your language program, not a sales pitch.
Why medical translation is different
Medical and life sciences content carries consequences that ordinary business translation does not. A mistranslated dosage, contraindication, instruction for use, or informed consent form can harm a patient, delay a submission, or fail an audit. Several regulatory frameworks also require that information be made available in the official languages of the markets where a product is sold; a device or drug cannot be legally distributed if that information is not accurately translated. That is why medical translation demands linguistic mastery and subject-matter expertise — not one or the other. A single mistranslated unit on a dosage line, or a vague rendering of a contraindication, can trigger a recall, a clinical hold, or real harm, which is why review, not just translation, sits at the heart of the work.
That is also why generalist providers struggle in this field. Dependable medical translation services rest on three things at once: translators who genuinely know the subject, a second-linguist review that catches what one person can miss, and a process built for medical document translation at any scale — from a single informed consent form to a multi-country regulatory submission. We built our medical translation services around that combination rather than around the lowest possible price.
The Translation Company difference
Most buyers in this field choose between faceless global agencies and commodity, price-first vendors. We are deliberately a third option: a selective, partner-grade firm that takes on a focused group of clients and stands behind every word.
- Women-owned and WBENC-certified. A genuine procurement advantage inside enterprise and government supplier-diversity programs — not just a badge.
- Family-run, professionally staffed. The continuity and care of a family firm, backed by a seasoned team and a modern production network.
- Principal-level accountability. You deal with ownership, not a rotating junior account manager. Qualified buyers can speak with our CEO directly.
- One partner for the whole language program. Translation, editing, subject-matter review, formatting and DTP, multi-format delivery, interpreting, and publishing — under one accountable roof, with fewer handoffs.
- Two decades of medical track record. Operating since 2005, with experience across more than 70 medical fields.
How we work: human expertise, AI used with judgment
Buyers are right to ask how their content is produced. Our answer is straightforward: technology assists, qualified people decide, and every medical file is reviewed by a human. Concretely, that means client terminology and glossaries are enforced before any drafting begins; confidential clinical documents are handled securely, not pushed through public machine-translation tools; a subject-matter linguist translates; and a second qualified linguist revises, following an ISO 17100-aligned two-step process. The result is the speed of modern tooling with the accountability a regulated buyer needs.
In practice, every project follows the same path: prepare and enforce terminology, translate with a subject-matter linguist, revise with a second linguist, run quality and consistency checks, and deliver with a certificate of accuracy where it is required.
Certified medical translation and accuracy
When you need a certified medical translation, we issue a signed certificate of accuracy attesting that the translation is true and complete — the form accepted for regulatory, legal, and institutional purposes. For clinical outcome assessments and patient-reported outcomes, we also offer back-translation and reconciliation, so meaning is verified rather than assumed. Our certified medical translation services pair that documentation with the same two-linguist review we apply to every file, and a certificate is available on request for any project that requires one.
Linguistic validation and back-translation
For patient-reported outcomes (PROs), clinical outcome assessments (COAs), and other instruments fielded across countries, accuracy is established through linguistic validation: forward translation by two independent linguists, reconciliation, back-translation, and cognitive debriefing with patients. We provide that rigor wherever a regulator or ethics committee requires it, so an instrument means the same thing in every language it is used in.
Who we serve
- Clinical research and CROs — protocols, clinical trial documents, informed consent forms, and patient-facing materials.
- Pharmaceutical companies — drug labeling, submissions, and pharmacovigilance content.
- Medical device manufacturers — instructions for use, labeling, and software under EU MDR and IVDR.
- Hospitals and health systems — patient documents and healthcare communication, with attention to confidentiality.
- Biotechnology and universities — research, patents, and regulatory documentation.
Across all of these, we act as a single life sciences translation partner rather than a chain of disconnected vendors: one team owns terminology, quality, and delivery from the first file to final publication. Choosing a medical translation company you can keep is the whole point — consistency compounds over a program, and rework is expensive once a wrong term has already shipped to a label or a portal.
Medical specialties we translate
We work with translators who specialize in specific medical fields and have in-depth knowledge of their area of practice, including:
- Anesthesiology
- Cardiology
- Gastroenterology
- Genetics
- Geriatrics
- Immunology
- Infectious Diseases
- Neurology
- Obstetrics and Gynecology
- Oncology
- Ophthalmology
- Orthopedics
- Pathology
- Pediatrics
- Psychiatry
- Radiology
- Rheumatology
- Toxicology
In total, we have translators specializing in over 70 medical fields. We also provide medical interpreting and medical transcription, on site near our offices and over the phone nationwide.
Medical documents we translate
Different organizations rely on specialized medical translation when entering new markets or serving diverse patient groups — pharmaceutical companies, biotechnology firms, medical device manufacturers, research universities, and hospitals. Documents we routinely handle include:
- Trials and testing: clinical protocols, clinical trials, medical research
- Forms and reports: case report forms, informed consent forms (ICFs), toxicology reports
- Patient information: patient information sheets, patient-reported outcomes, medical records
- Contracts and applications: drug registration documentation, medical contracts, regulatory documents
- Labels, manuals, and instructions: pharmaceutical package inserts and labels, physician manuals, surgical instructions, medical device manuals and instructions for use
- Articles and studies: scientific and medical journal articles, pharmacological studies, peer-reviewed experiments, clinical data
We also routinely handle adverse event reports, clinical study reports, standard operating procedures (SOPs), and regulatory submissions for the FDA, EMA, and other authorities.
Translators must also tailor each text to its audience. A clinical trial protocol uses precise scientific terms, while an informed consent form must use everyday language a subject can genuinely understand — and terminology has to stay consistent throughout a document and across a program. That discipline, what the field calls terminology management, is central to how we work.
Quality and compliance
Our medical translation processes operate to the requirements of ISO 9001 (quality management) and ISO 17100 (translation services). For device and pharmaceutical work we align to the relevant frameworks our clients answer to, including the FDA, the European Medicines Agency (EMA), the EU Medical Device Regulation (EU MDR 2017/745) and IVDR, ISO 13485 for medical device quality systems, HIPAA for protected health information, and 21 CFR Part 11. Confidentiality is treated as a requirement, not a courtesy: we know how sensitive your documents are, and we handle them accordingly, and we can align to your security and data-handling requirements, including signed business associate agreements where HIPAA applies.
A specialist partner vs. the alternatives
| What matters in medical translation | Commodity / DIY machine translation | The Translation Company |
|---|---|---|
| Subject-matter linguist + second-linguist review | Rarely | Standard, ISO 17100-aligned |
| Enforced client terminology and glossaries | No | Yes, before drafting |
| Secure handling of confidential clinical data | Often public cloud | Controlled and confidential |
| Regulatory fluency (FDA, EMA, MDR/IVDR, HIPAA) | Limited | Built into the workflow |
| Accountability | Ticket queue | Principal-level, CEO-accessible |
Why clients stay with us
We have translated thousands of medical documents and advised regulated pharmaceutical, medical device, clinical research, and healthcare organizations around the world. What makes us different is not a slogan — it is how we treat the relationship. We take on clients selectively and look after them: to us, our clients are like family, and we do not rest until the work is right. If you are looking for a long-term medical translation partner rather than a one-off vendor, that is exactly what we are built for.
- Quality first. A defined, reviewed process for every medical file.
- Faster turnaround. We consistently deliver 30–50% faster than the industry standard, without sacrificing review.
- Range of languages. Deep coverage across the languages your markets require.
- Accountable ownership. Direct access to the people responsible for your program.
Frequently asked questions
Do you use machine translation or AI?
We use modern technology where it genuinely helps, but never unsupervised on medical content. AI may assist; a qualified human linguist translates or post-edits, and a second linguist reviews. Every medical file is human-verified.
Do you follow ISO standards?
Our quality and translation processes operate to ISO 9001 and ISO 17100. To be precise: we follow the requirements of those standards. We do not claim formal ISO certification, and we would rather state that accurately than overstate it.
Is your medical translation HIPAA compliant?
Yes. We handle protected health information confidentially and align our processes with HIPAA requirements. We are glad to discuss your specific data-handling and security needs.
How do you keep terminology consistent?
We build and enforce client glossaries and translation memories before drafting, so the same approved terms are used across every document and every update in your program. For long-running accounts that terminology becomes a shared asset we maintain on your behalf, which is part of why clients consolidate their medical translation services with a single partner.
How fast can you deliver?
It depends on volume and document type, but we typically run 30–50% faster than the industry standard while keeping the full review step. Tell us your deadline and we will be candid about what is realistic.
What does it cost?
Medical translation is priced to the work — language pair, volume, complexity, and turnaround. We meet your procurement model (per word, project, or managed program) as long as it pays for professional-grade quality. Start with a conversation and we will prepare a tailored approach.
Do you provide a certificate of translation accuracy?
Yes. For regulatory, legal, or institutional use we provide a signed certificate of accuracy with the translation, and we can arrange validation by a target-country professional where an IRB or ethics committee requires it.
Can you support a large or ongoing program?
Yes. We are built for continuity: dedicated project management, maintained translation memories and glossaries, and version control, so updates translate quickly and only the changed content is re-billed. Many clients consolidate their medical translation services with us precisely for that consistency over time.
Can you also provide medical interpreting and other languages?
Yes. Alongside translation we provide medical interpreting — on site near our offices and remotely nationwide — and we cover the languages your patient populations and markets require. If your program spans both documents and live encounters, one partner can handle both, which keeps terminology and tone consistent across everything your patients read and hear.
Explore our medical & life sciences services
Each part of your program has a dedicated team and a dedicated page:
- Clinical trial translation — protocols, informed consent forms, case report forms, and investigator brochures for CROs and sponsors.
- Pharmaceutical translation — drug labeling, regulatory submissions, and pharmacovigilance for the FDA and EMA.
- Medical device translation — instructions for use, labeling, and software under EU MDR and IVDR.
- Healthcare & HIPAA translation — patient documents and healthcare communication for hospitals and health systems.
- Life sciences translation — across regulatory affairs and medical affairs.
- Biotechnology translation — research, patents, and laboratory documentation.
- Medical interpreting — on-site, over-the-phone, and video remote interpreting for live patient encounters.
- Linguistic validation — COA and PRO instruments, cognitive debriefing, and back-translation.
- Medical interpreting — on-site, over-the-phone (OPI), and video remote (VRI) for live patient encounters.
Talk with us about your medical translation program
Start with a conversation, not a price tag. The best way to know whether we are a fit is to talk.
Book a complimentary strategy session with our CEO, Camila Saunier, best suited to organizations looking for a long-term medical translation partner. Have a project ready? Share the details and we will prepare a tailored quote and approach. Questions? Email [email protected] or call 800.725.6498.