In the European Union (EU), it is essential for medical device manufacturers to maintain compliance with CE marking requirements. These regulations govern product documentation and ensure that users have access to information in their native language.

As a result, accurate translation of all medical technology and device documentation, including instructions for use (IFUs) and labeling in the country’s native language is crucial. ILS is a translation company experienced in CE mark requirements to make certain that your materials are compliant with and meet the needs of European standards.


Instructions for Use (IFU) Translations

Translated medical device instructions are critical for compliance with regulatory entities. Our team of native-speaking translation professionals helps clients translate their IFUs for proper use by patients. We reduce the complexity of the IFU translation process by partnering you with a team that features native speakers and experts in quality control.

  • IFUs (Instructions for Use)
  • Operation Manuals
  • User Guides
  • Safety Instructions
  • Multimedia Presentations & Training Manuals

Packaging & Product Labeling

When exporting goods to European countries, it is essential that the packaging and labeling meet the requirements of the destination country. In some cases, this may mean using bilingual or multilingual labeling, as well as providing instructions in the local language. ILS can pair you with native-speaking translation experts who can help you meet the needs of your target audience. We can provide translation and localization services for all your packaging and labeling requirements, ensuring that your products comply with European regulations.

Regulatory and Legal Documentation

At ILS, we understand that accurate translation is essential for meeting regulatory and legal requirements. That’s why our translation teams are familiar with the surrounding documents and file formats associated with medical, clinical, and export requirements. We ensure that our translations are accurate and compliant with all relevant regulations.

CE Mark Translations for Medical Technology

In order to ensure that medical devices are properly understood by the people who use them, the CE mark directives require that various documents and information be supplied in the national languages of the users. This includes not only the user manual but also warning labels and instructions for use. To ensure that these materials are accurately translated, we only use native speakers who are familiar with your technical medical documents. This allows for a translation that is both culturally sensitive and idiomatic with materials that are properly understood by those who need to use them.

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Why Choose International Language Services, Inc.?

High-Quality Translations

ILS is committed to providing high-quality translation results through native translators, talented project managers, and rigorous in-house quality control teams. We also take advantage of 9001:2015 certification for added quality assurance

Competitive Pricing

By combining our talented teams with state-of-the-art technology, we’re able to provide translation services for CE marking compliance at a competitive price point. Our translation solutions help a wide range of industries get the resources they need within their budget.


Localization is a crucial component in translations to accurately convey source materials. We offer localized technical translation solutions to ensure your units of measurement, cultural references, idiomatic expressions, and metaphors are correct in their intended audience’s language.

Technical Translators

We partner you with native speakers who are knowledgeable about your industry’s unique subject matter, file formats, and technical terminology for accurate results the first time around. We partner our translators with detail-oriented project managers who coordinate your projects for fast delivery.

Guaranteed On-Time Delivery

We understand how crucial timely delivery is for your translation needs. Even with CE marking compliance, we continue to keep your projects on track. Our designated project managers work with our translators to ensure that all deadlines are met.

In-House Quality Control

We provide in-house quality control to ensure that your CE marking compliance is correct for your technical translations. Our professional QC team proofs, edits, and ensures correct file formatting for your translation projects, resulting in accurate and consistent translations for every project.

Superior Communication and Service

ILS is committed to serving businesses and manufacturers that rely on CE marking compliance through high-quality translations, reliable service, and fast delivery. We match you with experienced native translators in your target language to ensure that your translations are accurate and idiomatically sound.

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Our Languages

ILS offers CE mark translation solutions in a diverse range of languages. Our native translators are knowledgeable in file formats and technical terminology in order to provide clear and precise translations. Our most common language translation requests for CE marking include the following:

  • German

  • Spanish

  • French
  • Italian
  • Dutch
  • Polish
  • Portuguese
  • Czech
  • Greek
  • Swedish
  • And more

Translation Solutions For Your Industry

ILS provides accurate and reliable translation services for technical industries operating throughout the global marketplace. We only work with experienced translators who are familiar with the terminology and file formats used in your industry, ensuring that your documents are translated correctly the first time.

In addition, we build living databases of frequently used terms, phrases, and file formats for each of our clients. This allows us to quickly and easily translate future documents, saving you time and money. We supply concise translations for the following industries:

  • Automotive

  • Food Processing

  • Agrochemical

  • Industrial Chemical

  • Mining & Petroleum

  • Medical & Healthcare Manufacturing

  • Industry Control Systems
  • And more…

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