Case Study: Translating IFUs for Medical Devices

With medical devices, it is vital for people to understand exactly how to use a product and to be clear about any warnings associated with the product. Read about how Comms has helped one client to translate their IFUs.
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It is actually a legal requirement in many countries for items such as medical devices to have instructions for use translated into the local language for the market in which the product is to be sold.


A customer in the medical devices sector came to us as they wanted to launch a particular product in certain European countries.

In order to be able to launch this product in Europe, they therefore needed to produce an “Instructions for Use” manual in 12 languages. They wanted to have all the languages, including English, in one manual.

Process steps


As our client didn’t have a template for this manual in English, we designed this guide from scratch to a size that would fit into their packaging.

We also provided samples of different types of paper, so that our client could choose the most appropriate for their requirements.


We translated the text using translators with expertise in the translation of documents for the medical devices sector. The translation was then independently proofread in order to ensure quality, as is our standard practice.

As is normal in this sector, the translations were submitted for regulatory approval and they passed with flying colours.

Typesetting and Printing

We then typeset the different languages and produced a PDF for approval. Once this was approved, we printed 3,000 copies and delivered them to our delighted client, completely ready to ship with the product.

This was all completed within a couple of months, allowing our client to get the product out to the marketplace on time and within budget.

Always ask to see a low-res PDF before printing so that you can make any changes necessary at that stage and sign off the document.


Since then, our customer has been so successful that they commissioned us to print more copies! They then decided to move into other countries as well and we have now added 3 further languages to the original manual.

Having been very successful with one product, our client is now moving forward with offering other products of theirs internationally as well and we are heavily involved in the design, translation, typesetting and printing of product manuals for these products.

Please contact us with the details of your projects and we will be happy to provide you with a quotation.

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