Medical translation is the practice of translating various documents—training materials, medical bulletins, drug data sheets, etc.—for health care, medical devices, marketing, or for clinical, regulatory, and technical documentation. Most countries require that companies and organizations translate literature and labeling for medical devices or pharmaceuticals into their national language. Documents for clinical trials often require translation for local clinicians, patients, and regulatory representatives. Regulatory approval submissions typically must be translated. In addition to linguistic skills, medical translation requires specific training and subject matter knowledge because of the highly technical, sensitive, and regulated nature of medical texts.
Process
Medical translation steps can include:
* Extracting text from the source format
*
Translating
Translation is the communication of the meaning of a source-language text by means of an equivalent target-language text. The English language draws a terminological distinction (which does not exist in every language) between ''transl ...
text to the target language
* Editing by a separate person to assure adherence to approved terminology and proper style and voice
* Publishing the translation in the original format (e.g., Word document, Web page, e-learning program)
*
Proofreading to ensure the formatted translation has proper punctuation and line and page breaks, and displays correctly
* Reviewing in-country by a native-speaking expert to ensure the translation meets all requirements
Translation agencies may oversee both project management and linguistic aspects.
Quality and standards
The life and death nature of medical texts mandates a strong emphasis on translation quality. The international medical industry is highly regulated, and companies who must translate documentation typically choose translation agencies certified or compliant with one or more of the following standards:
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EN 15038 — European standard for translation vendor quality (
Translation-quality standards
Like any supplier of goods or services, a translator potentially bears ethical and legal obligations toward his patron or employer. This has turned to be of enormous importance with the development of the language industry at global scale. For t ...
)
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ISO 9001
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO ...
— Quality system standard
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ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive ...
— Overarching standard for medical device manufacture
Because of the high amounts of specificities, regulations, and challenges in the field of medical translation, some specialized translation companies have emerged who deal with medical translations exclusively. Some of these companies have hired medical practitioners to supervise the translation process.
See also
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Tremédica
The International Association of Medical Translators and Writers and Related Sciences ( es, Asociación Internacional de Traductores y Redactores de Medicina y Ciencias Afines, acronym Tremédica) is an international organization devoted to the pr ...
References
External links
The Challenges of Selling in Multiple Markets
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Translation
Academic works about medicine