Life sciences translation experts

IFU Translations

IFUs (Instructions for Use) are extremely important documents that set out instructions for how to use medical products safely and effectively. For certain products, IFUs are a mandatory regulatory requirement, and translation is key to ensuring patients and HCPs around the world understand instructions with total clarity.

The content of IFUs is often highly-technical but must be understood by both HCPs and laypeople. That’s where Conversis comes in – with in-country medical linguists who ensure clarity, accuracy, and regulatory compliance.

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Why are IFU Translations Important?

IFUs offer step-by-step guidance on how to use a product, keeping people safe and promoting better health outcomes. Translation is essential to ensure IFUs are meaningful and effective for all users.

Ensures everyone in a clinical trial is using a product consistently, so results are comparable and interpretable.
Mandated by regulatory bodies like the EMA or FDA for certain products.
Translation required in up to 25 languages under the EU MDR.
Updates must be quickly reflected across all languages in the case of new safety information or regulations.
IFUs are legal documents, so errors or mistranslations can have legal consequences.

Our IFU Translation Services.

We have been translating IFUs for our clients for 20+ years, so we know better than most how to produce content that’s understandable to both HCPs and laypeople. Our linguists are experts in the field, who also live in-country, within their communities. This means we can translate IFUs into 330+ language combinations, including regional and rare ones, so our clients can speak to all communities in terms they will truly understand.

International regulatory bodies, like the EMA, FDA, and PMDA, have specific requirements in terms of IFU content and how it should be presented. We help our clients follow regulatory frameworks to ensure their content meets the requirements of all major bodies globally.

We regularly assist our clients with 25-language IFU translations, and with any subsequent updates that arise from changes to regulation or safety information. Our custom AI tools allow us to rapidly allocate this work to the best possible linguists, automate formatting tasks and manage terminology databases, ensuring consistent use of approved terms across all versions.

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Translation Process

Our IFU Translation Process.

Each of our clients is matched with a dedicated project team, who takes the time to understand their unique needs, goals, and preferred ways of working. For each new project, they will analyze materials and advise on the best approach to take.

For IFUs, depending on language combinations and complexity, they may suggest workflows enabled by our custom AI tools, human-only translation, or a hybrid approach. In all cases, content will be finalized by our expert linguists, before being QA’d by our in-house QA team.

Depending on format and client preferences, we can offer DTP services, client review, and certification, and we’re always happy to advise on cultural appropriateness.

Why Work With Conversis.

Specialists in life sciences

Providing IFU translation since 2003

3,000+ linguists

330+ language combinations

People on the ground in 110 countries

All linguists are specialists in life sciences

Regularly handle 25-language projects

Certified ISO 9001, 17100 & 27001

Track record in 50+ therapeutic areas

Coverage of entire product lifecycle

Custom AI for life sciences translation

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Trusted by organizations all over the world

What our clients say about working with us.

“Working with the Conversis team has been a very positive experience. They are flexible, proactive, attentive to our needs, consistently respectful of deadlines, and dedicated to delivering the best possible outcome”

Survey Project Manager at EURORDIS

“I know some of the requests on these studies have not been typical and we have asked a lot of Conversis, but you really have stepped up and delivered. With your attention to detail, knowledge of the processes, diligence, and hard work to ensure the job gets done, you have made a significant impact on the work we are able to deliver here at IQVIA.”

Shelby Terry, Senior Patient Recruitment Specialist at IQVIA

“The team was always approachable throughout the entire project and worked effectively so that we were able to meet our tight deadline. The linguist’s understanding of the biology and technical aspects of the project resulted in the production of a highly competent translated document. We can therefore only recommend their work.”

Silke Fuchs, Regulatory Scientist at Target Malaria

Case Studies.

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IFU Translation Services in Over 330 Language Combinations:

Our extensive network of linguists spans the globe, with experts residing in their respective countries, covering all regions worldwide. This means we can help ensure your IFU translations meet requirements for all major regulatory bodies, and speak to all HCPs and patients globally.

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FAQs About IFU Translations.

What is an IFU?

An IFU (Instructions for Use) sets out clear instructions for using a medical product. It is usually used by HCPs and/or patients, and is intended to ensure a product is used safely and effectively.

What are the requirements for IFU translations?

IFU translations must be clear and accurate, and be written in a way that can be understood both by medical professionals and laypeople. For some products, translation is a regulatory requirement, and under the EU MDR, translation could be required in up to 25 languages. Any changes made to the original IFU must be quickly reflected in all language versions.

How long do IFU translations take?

IFU translation times depend on factors such as language combinations, length of document, and service level.

If you would like to know how long your IFUs would take to translate, please get in touch and we will be happy to assess and provide a quote and timeline for you.

What are the challenges in translating IFUs?

The main challenges of translating IFUs are:

Technical content – Translators must be experts in the subject matter
Diverse audience – Translations must be appropriate for both HCPs and laypeople
Regulatory requirements – Must be completed by in-country regulatory experts
Legal implications – Errors may have legal ramifications
Number of languages – IFUs may need to be translated into 25 languages concurrently
Updates – New safety or regulatory information must be quickly reflected across all languages