Linguistic validation in the healthcare sector: learn about the entire process



A translated text should faithfully reproduce what is written in the original text, but in another language. However, for a translation to sound original, will a mere word-by-word translation be enough?



Translation and linguistic validation for MedTech and Pharmaceutical companies


Did you know that, in 2020, demand for translation services in the healthcare sector was up 49%, and up 38% in the pharmaceutical sector?¹ 

Both medical and pharmaceutical translation, as well as linguistic validation, are increasingly more common and necessary services in these sectors. Do you know why? Because each and every year we witness the entry of new medications and medical devices in the market, as well as the expansion of this sector’s companies into international markets. Consequently, the need for companies to have key documents written in multiple languages – instructions for use, labels, safety data sheets, information manuals, regulatory documents and advertising and marketing materials – increases as well.

Therefore, the demand for translation, revision and document validation services with high quality and certification is dramatically on the rise.


     What is the difference between medical translation and linguistic validation?


While medical translation consists of interpreting texts involving the healthcare sector and reproducing them in another language, linguistic validation consists of assessing a document translated by natives in that language. This will ensure that the content is localized not only to the language, but also to the culture of its target audience.


Imagine that your doctor gives you a list of recommendations for a healthier lifestyle. This list has one point which says: “run 8 kilometres every day” and “eat just 100 grams of cereal for breakfast.” Do you understand these recommendations? Do you feel that the document has been correctly localized to your culture?


     The complete linguistic validation process


  1. Translation 

    The translation method here is slightly different from normal. When undergoing a linguistic validation process, a document is sent to at least two different translators – ideally, natives in the intended target language. The results of the translations are then compared, with a reviser in charge of combining the best of the two versions, thereby arriving at the first translation of the original document.
  2.  Backtranslation

    The translation process is reversed, i.e. the first version of the translation is translated back into the original language. The new translators should have no access to previous documents. After comparing the backtranslation against the original document, any necessary changes are made, resulting in the second version of the translation.


  3. Validation of content

    The goal of this phase is to test the translation with a target audience sample group. Take the example of a package leaflet of a medication. In this phase, the leaflet is shared with several patients who take the medication, and the patients are asked to interpret it. This stage ensures a consistent connection between the translation and the culture of the target audience, validating the material in an appropriate manner for the document’s destination country. Once this process is complete, the final version of the translation is reviewed to make sure there are no mistakes.

Confusing? The following diagram shows the simplified process.


This process may seem extremely complex, but it is necessary to properly verify all content in the document. In the medical and pharmaceutical sector, using ounces or grams, kilometres or miles can make all the difference in interpreting content, and misinterpretations can have serious consequences. Only with a linguistic validation process will you be able to have documents written in multiple languages, with the desired linguistic and scientific quality, and correctly interpreted by the intended target audience.


¹, accessed in September 2021.


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