- What kinds of documents are covered by medical translation?
- What does the medical translation process look like?
- Who should handle clinical translations?
Medical translation is one of the most challenging types of translation – it demands precise language and carefully chosen terminology. In this field, the stakes are high: the patient’s health, and sometimes even their life. What might seem like a minor wording mistake could lead to a medication error or distort a diagnostic report. Today, hospitals, clinics and pharmaceutical companies increasingly work with professional translators to ensure that medical documentation and related materials meet strict quality standards.
What kinds of documents are covered by medical translation?
The range of materials translated in the medical field is extensive. Translation agencies most commonly handle:
– hospital discharge summaries and patient case notes,
– lab results, radiology reports and diagnostic imaging records,
– clinical trial protocols and informed consent forms,
– medication leaflets, summaries of product characteristics, and packaging labels,
– operating manuals for medical devices and training kits for staff,
– scientific articles, conference posters and presentations,
– regulatory documentation required by the EMA or FDA (e.g. investigational medicinal product dossiers),
– ISO procedures and medical device conformity reports.
In practice, the list is even longer. It also includes letters of intent for technology transfer or correspondence between hospitals and foreign institutions. If a hospital maintains a website, this content may also need translation. The same applies to patient-friendly publications and educational materials.
What does the medical translation process look like?
Professional medical translation is a multi-stage process. First, the content is carefully extracted from the source file. A specialist translator then renders the text using correct terminology for the target market, aligned with classification systems such as ICD-10 and MedDRA.
Once the initial translation is complete, the document is passed to a second linguist or editor who reviews terminology and stylistic consistency – this is standard under ISO 17100, the quality benchmark followed by most reputable agencies. The next step is formatting reconstruction, which is crucial for elements such as drug labels or interactive forms. Finally, a dedicated QA team performs a technical check of units, study identifiers and personal data, often using specialised CAT tools. Medical translation takes longer than standard texts, but the extended timeline helps minimise the risk of critical errors.
Who should handle clinical translations?
Medical translation requires a unique blend of linguistic and healthcare expertise. Most translators in this field are language graduates with additional medical qualifications, or professionals like doctors and pharmacists who have completed postgraduate training in translation. Hands-on experience with hospital documentation, patient leaflets or clinical trial protocols is essential – it ensures familiarity with abbreviations, proprietary drug names and the specific procedures used in areas like oncology or cardiology.
A professional should also be familiar with the regulatory frameworks of bodies such as the European Medicines Agency and the FDA, know how to handle confidential data, and understand the practical aspects of GCP (Good Clinical Practice) guidelines. They should be proficient in CAT tools, know how to build and manage glossaries, and stay current with developments in new therapies. If a certified translation is required, the translator must also be registered as a sworn translator in their country and follow the statutory rules for that role.
When commissioning clinical translations, it’s important to choose someone with proven experience. Cost-cutting in this area can lead to serious consequences – both for patient safety and for your organisation’s legal and professional standing.