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Accurate IFU Translation for Global Medical Device Compliance

Sesen delivers regulatory-grade IFU translations in over 100 languages, helping medical device companies meet MDR, IVDR, and FDA requirements with precision and speed.


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The Foundation of Global Device Success: IFU Translation

Instructions for Use (IFU) are critical documents that provide end users—healthcare professionals, patients, and technicians—with essential information on how to safely and effectively use a medical device. IFUs may include indications, contraindications, warnings, step-by-step usage instructions, and maintenance procedures.

For medical device manufacturers operating globally, accurate IFU translation is not optional—it’s a regulatory necessity. International regulations such as the EU MDR (2017/745), IVDR (2017/746), and FDA requirements mandate that IFUs be translated into the official languages of each target market to ensure product safety and usability.

Mistranslations can have severe consequences: improper device usage, delayed treatments, adverse events, regulatory non-compliance, or even forced product recalls. That’s why choosing a language services partner with deep life sciences expertise is essential for both regulatory compliance and patient safety.

At Sesen, we specialize in high-accuracy IFU translation tailored to the medical device industry—supporting your global distribution and protecting your brand from risk.

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IFU Translation Workflow for Regulatory Success

IFU Translation Workflow

Our process ensures each IFU is linguistically accurate, technically compliant, and properly formatted for submission to global regulatory authorities. Once the source-language IFU is finalized, we manage the entire localization lifecycle, from multilingual translation and regulatory QA to DTP and submission-ready output for CE, FDA, and other global requirements.

Why IFU Translation Matters

Accurate and compliant IFU translation is critical for medical device manufacturers navigating complex global regulations and multilingual markets. Sesen delivers high-quality IFU translations that support regulatory approval, enhance user safety, and accelerate global market access.

Under the EU MDR and IVDR, medical device companies are required to provide Instructions for Use in the official languages of each EU member state. Similar regulations exist globally, including FDA labeling guidelines in the U.S., Health Canada, PMDA (Japan), ANVISA (Brazil), and others. Noncompliance can lead to market access delays, fines, or failed audits.

Inaccurate or poorly translated IFUs increase the risk of misuse, adverse events, and potential product recalls. Clear, consistent translations help reduce liability exposure and support post-market surveillance readiness.

Professionally translated IFUs enhance end-user comprehension—whether the user is a clinician, technician, or patient—directly contributing to better treatment outcomes and safer device operation.

Accurate, localized IFUs are essential for launching medical devices across EU, LATAM, APAC, and MEA markets. Sesen helps medical device companies streamline the multilingual documentation process, enabling faster product rollouts without compromising quality or compliance.

Under the EU MDR and IVDR, medical device companies are required to provide Instructions for Use in the official languages of each EU member state. Similar regulations exist globally, including FDA labeling guidelines in the U.S., Health Canada, PMDA (Japan), ANVISA (Brazil), and others. Noncompliance can lead to market access delays, fines, or failed audits.

Inaccurate or poorly translated IFUs increase the risk of misuse, adverse events, and potential product recalls. Clear, consistent translations help reduce liability exposure and support post-market surveillance readiness.

Professionally translated IFUs enhance end-user comprehension—whether the user is a clinician, technician, or patient—directly contributing to better treatment outcomes and safer device operation.

Accurate, localized IFUs are essential for launching medical devices across EU, LATAM, APAC, and MEA markets. Sesen helps medical device companies streamline the multilingual documentation process, enabling faster product rollouts without compromising quality or compliance.

Sesen’s Expertise in IFU Translation

At Sesen, we specialize exclusively in life sciences translation, with deep domain expertise in medical device documentation, including Instructions for Use (IFUs). Our end-to-end translation solutions are designed to meet the highest standards of quality, regulatory compliance, and linguistic precision.

Our specialized focus ensures that every IFU translation is handled by linguists and subject matter experts who understand the regulatory, scientific, and clinical context of your medical devices.

Sesen’s translation processes are certified to ISO 13485:2016, ISO 17100, and ISO 9001:2015—ensuring repeatable quality and full traceability. These certifications reflect our commitment to quality assurance in regulated environments.

We assign translators with proven expertise in medical device terminology, including surgical instruments, diagnostic devices, combination products, and software-driven technologies. Terminology accuracy is supported through approved glossaries and translation memories.

Each IFU translation undergoes multi-step quality review, including bilingual editing and final checks by in-house regulatory and linguistic reviewers familiar with MDR, IVDR, and FDA requirements.

Our multilingual DTP team ensures your translated IFUs retain proper formatting, structure, and layout across all languages—meeting region-specific labeling and readability standards, whether for printed inserts or eIFUs.

Our specialized focus ensures that every IFU translation is handled by linguists and subject matter experts who understand the regulatory, scientific, and clinical context of your medical devices.

Sesen’s translation processes are certified to ISO 13485:2016, ISO 17100, and ISO 9001:2015—ensuring repeatable quality and full traceability. These certifications reflect our commitment to quality assurance in regulated environments.

We assign translators with proven expertise in medical device terminology, including surgical instruments, diagnostic devices, combination products, and software-driven technologies. Terminology accuracy is supported through approved glossaries and translation memories.

Each IFU translation undergoes multi-step quality review, including bilingual editing and final checks by in-house regulatory and linguistic reviewers familiar with MDR, IVDR, and FDA requirements.

Our multilingual DTP team ensures your translated IFUs retain proper formatting, structure, and layout across all languages—meeting region-specific labeling and readability standards, whether for printed inserts or eIFUs.

Types of IFU Documents We Translate

Sesen provides comprehensive IFU translation services across a wide range of medical device categories. Whether you’re launching a Class III implantable device or a digital health solution, we translate IFUs and related materials with precision, consistency, and regulatory alignment.

We translate Instructions for Use for a wide spectrum of Class I, II, and III medical devices, including orthopedic implants, stents, infusion pumps, and external medical tools.

Our linguists specialize in translating high-precision documentation for surgical tools, including reusable and single-use instruments, with clear step-by-step guidance and safety protocols.

Sesen supports IFU translations for software as a medical device (SaMD) and embedded medical technologies, ensuring compliance with labeling and usability standards for digital interfaces.

We provide multilingual translation and XML formatting support for eIFUs, helping device manufacturers meet digital documentation requirements across regulated markets.

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Our team translates and formats patient-facing materials that accompany medical devices, ensuring they are culturally adapted and medically accurate for global audiences.

Sesen delivers regulatory-compliant translations for companion diagnostic devices, ensuring alignment with associated therapeutic products and supporting clinical interpretation.

We handle hybrid documentation that merges labeling content and Instructions for Use, maintaining consistency across all languages and file types for global submission packages.

We translate Instructions for Use for a wide spectrum of Class I, II, and III medical devices, including orthopedic implants, stents, infusion pumps, and external medical tools.

Our linguists specialize in translating high-precision documentation for surgical tools, including reusable and single-use instruments, with clear step-by-step guidance and safety protocols.

Sesen supports IFU translations for software as a medical device (SaMD) and embedded medical technologies, ensuring compliance with labeling and usability standards for digital interfaces.

We provide multilingual translation and XML formatting support for eIFUs, helping device manufacturers meet digital documentation requirements across regulated markets.

Learn more

Our team translates and formats patient-facing materials that accompany medical devices, ensuring they are culturally adapted and medically accurate for global audiences.

Sesen delivers regulatory-compliant translations for companion diagnostic devices, ensuring alignment with associated therapeutic products and supporting clinical interpretation.

We handle hybrid documentation that merges labeling content and Instructions for Use, maintaining consistency across all languages and file types for global submission packages.

Regulatory Compliance in IFU Translations

Sesen’s IFU translation services are fully aligned with global regulatory frameworks, helping medical device manufacturers meet stringent submission requirements across international markets. Our expertise in multilingual compliance ensures your documentation is audit-ready, linguistically accurate, and regionally appropriate.

We support full-language compliance with EU MDR 2017/745, including IFU translations for all device classes. Our processes meet EU expectations for linguistic clarity, end-user readability, and language localization across all official EU languages.

Sesen provides compliant IFU translations for in vitro diagnostic devices under EU IVDR 2017/746, addressing the specific requirements for scientific accuracy, diagnostic context, and multilingual accessibility.

Our team is experienced with FDA 21 CFR Part 801 and UDI (Unique Device Identification) labeling standards. We help clients deliver IFUs that meet FDA expectations for instructional content, readability, and electronic labeling formats.

We deliver regulatory-aligned IFU translations for Health Canada, PMDA (Japan), SFDA (China), ANVISA (Brazil), TGA (Australia), and other global authorities—each with unique language and submission standards.

Sesen adheres to recognized terminology frameworks including MedDRA (Medical Dictionary for Regulatory Activities) and EDQM (European Directorate for the Quality of Medicines), ensuring terminological consistency and harmonization across all translated documents.

We support full-language compliance with EU MDR 2017/745, including IFU translations for all device classes. Our processes meet EU expectations for linguistic clarity, end-user readability, and language localization across all official EU languages.

Sesen provides compliant IFU translations for in vitro diagnostic devices under EU IVDR 2017/746, addressing the specific requirements for scientific accuracy, diagnostic context, and multilingual accessibility.

Our team is experienced with FDA 21 CFR Part 801 and UDI (Unique Device Identification) labeling standards. We help clients deliver IFUs that meet FDA expectations for instructional content, readability, and electronic labeling formats.

We deliver regulatory-aligned IFU translations for Health Canada, PMDA (Japan), SFDA (China), ANVISA (Brazil), TGA (Australia), and other global authorities—each with unique language and submission standards.

Sesen adheres to recognized terminology frameworks including MedDRA (Medical Dictionary for Regulatory Activities) and EDQM (European Directorate for the Quality of Medicines), ensuring terminological consistency and harmonization across all translated documents.

Our IFU Translation Process

At Sesen, our IFU translation process is purpose-built for regulatory precision, linguistic accuracy, and seamless integration with your global product launch timelines. Each step is designed to deliver high-quality, audit-ready documentation that aligns with international compliance standards.

We begin with a detailed review of your IFU content, identifying technical terms, regulatory references, and device-specific language. Approved glossaries and client-specific style guides are developed or integrated to ensure terminology consistency across all languages.

Translators are selected based on subject matter expertise in your device category—whether surgical instruments, diagnostic devices, or software-driven products. All linguists are native speakers of the target language and trained in medical and regulatory terminology.

Each IFU undergoes a multi-step linguistic workflow: initial translation, bilingual editing, and optional in-country review by native-speaking medical professionals to ensure local market relevance and compliance.

Our in-house DTP specialists format your translated IFUs to match original layouts, meeting EU readability standards, eIFU XML specifications, and device labeling regulations across multiple jurisdictions.

Every deliverable is subjected to rigorous QA, including terminology verification, LQA scoring, and readability testing. We ensure each translation meets regulatory and linguistic standards for submission.

Completed IFUs are delivered in your required format—PDF, XML, InDesign, or structured data—with optional support from our regulatory consultants to prepare documentation for CE marking, FDA submissions, or other global approvals.

We begin with a detailed review of your IFU content, identifying technical terms, regulatory references, and device-specific language. Approved glossaries and client-specific style guides are developed or integrated to ensure terminology consistency across all languages.

Translators are selected based on subject matter expertise in your device category—whether surgical instruments, diagnostic devices, or software-driven products. All linguists are native speakers of the target language and trained in medical and regulatory terminology.

Each IFU undergoes a multi-step linguistic workflow: initial translation, bilingual editing, and optional in-country review by native-speaking medical professionals to ensure local market relevance and compliance.

Our in-house DTP specialists format your translated IFUs to match original layouts, meeting EU readability standards, eIFU XML specifications, and device labeling regulations across multiple jurisdictions.

Every deliverable is subjected to rigorous QA, including terminology verification, LQA scoring, and readability testing. We ensure each translation meets regulatory and linguistic standards for submission.

Completed IFUs are delivered in your required format—PDF, XML, InDesign, or structured data—with optional support from our regulatory consultants to prepare documentation for CE marking, FDA submissions, or other global approvals.

Supported Languages

Sesen provides professional IFU translation services in over 150 languages to support global medical device distribution and regulatory compliance. Our native-speaking linguists and in-country reviewers ensure that translated Instructions for Use meet local language requirements, cultural expectations, and regional readability standards.

We support all official EU languages, including French, German, Spanish, Italian, Dutch, Polish, Swedish, Czech, Greek, and more—meeting the multilingual compliance requirements of EU MDR and IVDR.

Our network includes certified medical translators for Japanese, Korean, Simplified Chinese, Traditional Chinese, Thai, Vietnamese, Indonesian, and other key Asian languages for market entry across APAC regions.

We offer expert IFU translations in Arabic, Hebrew, and Turkish, ensuring alignment with medical device regulations and labeling expectations in MENA markets.

Sesen delivers regionalized translations in Brazilian Portuguese and Latin American Spanish, supporting Health Authority submissions and market launches across LATAM, including Mexico, Argentina, Colombia, and Brazil.

We also provide translations in Russian, Ukrainian, Hindi, Bengali, and additional languages for global coverage, including emerging markets and multilingual populations.

Whether you require translations for printed IFUs, eIFUs, or multilingual packaging inserts, Sesen ensures language accuracy, regulatory consistency, and global readiness.

We support all official EU languages, including French, German, Spanish, Italian, Dutch, Polish, Swedish, Czech, Greek, and more—meeting the multilingual compliance requirements of EU MDR and IVDR.

Our network includes certified medical translators for Japanese, Korean, Simplified Chinese, Traditional Chinese, Thai, Vietnamese, Indonesian, and other key Asian languages for market entry across APAC regions.

We offer expert IFU translations in Arabic, Hebrew, and Turkish, ensuring alignment with medical device regulations and labeling expectations in MENA markets.

Sesen delivers regionalized translations in Brazilian Portuguese and Latin American Spanish, supporting Health Authority submissions and market launches across LATAM, including Mexico, Argentina, Colombia, and Brazil.

We also provide translations in Russian, Ukrainian, Hindi, Bengali, and additional languages for global coverage, including emerging markets and multilingual populations.

Whether you require translations for printed IFUs, eIFUs, or multilingual packaging inserts, Sesen ensures language accuracy, regulatory consistency, and global readiness.

Technology-Enabled Human Translation

At Sesen, we combine the precision of human subject matter experts with industry-leading translation technology to deliver scalable, high-quality IFU translations that meet global compliance requirements and accelerate time to market.

We leverage advanced translation memory (TM) tools and client-approved terminology databases to ensure linguistic consistency across IFUs, reduce turnaround times, and lower translation costs for repeat or similar content.

Our platform integrates with your content management system (CMS) or product lifecycle management (PLM) system, enabling seamless data exchange and workflow automation for version-controlled IFU updates and regulatory submissions.

Sesen supports a wide range of structured content formats, including XML, InDesign, FrameMaker, and DITA, ensuring that translated IFUs maintain proper formatting, structure, and tagging for both print and digital distribution.

For high-volume, time-sensitive IFU projects, we offer machine translation with human post-editing (MTPE) as a cost-effective solution—performed by linguists with medical device expertise to meet quality and compliance benchmarks.

We leverage advanced translation memory (TM) tools and client-approved terminology databases to ensure linguistic consistency across IFUs, reduce turnaround times, and lower translation costs for repeat or similar content.

Our platform integrates with your content management system (CMS) or product lifecycle management (PLM) system, enabling seamless data exchange and workflow automation for version-controlled IFU updates and regulatory submissions.

Sesen supports a wide range of structured content formats, including XML, InDesign, FrameMaker, and DITA, ensuring that translated IFUs maintain proper formatting, structure, and tagging for both print and digital distribution.

For high-volume, time-sensitive IFU projects, we offer machine translation with human post-editing (MTPE) as a cost-effective solution—performed by linguists with medical device expertise to meet quality and compliance benchmarks.

Our technology-enabled workflows preserve accuracy and traceability while enabling efficient content reuse, localization at scale, and full regulatory readiness across global markets.

Electronic IFU (eIFU) Translation Services

Electronic IFU (eIFU) Translation Services

As more regulatory bodies permit or require electronic instructions for use (eIFUs), life sciences companies must adapt their documentation to meet digital compliance requirements. Sesen provides specialized eIFU translation services that combine linguistic accuracy with digital formatting expertise to support seamless, multilingual access to IFUs online.

Electronic Instructions for Use (eIFUs) are digital versions of traditional printed IFUs that are made available to users via a website or digital portal. eIFUs are increasingly used in the medical device and diagnostic sectors to:

  • Reduce environmental impact and printing costs
  • Enable real-time updates and version control
  • Improve accessibility across geographies and languages

eIFUs are subject to stringent regulations, particularly in the EU under MDR (Annex I, Chapter III, Section 23.1) and similar requirements from the FDA and other authorities.

Sesen supports end-to-end multilingual translation of eIFUs, including formatting and delivery in regulatory-compliant digital formats. Our services include:

  • XML/HTML Translation
    Our linguists work directly in structured formats such as XML or HTML to preserve tags, code integrity, and online rendering consistency.
  • Multilingual PDF Conversion
    We localize PDFs for download and offline access in accordance with eIFU hosting requirements.
  • EU MDR and FDA eIFU Compliance
    We support clients in meeting regional regulations for electronic IFUs, including digital access requirements, device traceability, and language availability.
  • Digital QA and Hyperlink Checks
    Our QA teams validate internal links, QR codes, and language toggling to ensure a smooth end-user experience in each target language.
  • Integration with Client Platforms
    We collaborate with your regulatory and IT teams to deliver translation-ready eIFUs for CMS, product portals, or UDI-linked systems.
  • Expertise in regulated digital content translation
  • Support for over 150 languages
  • Familiarity with structured formats including XML, XLIFF, and DITA
  • Proven track record working with EU MDR, FDA, and other international regulatory frameworks
  • Scalable support for high-volume device documentation

Electronic Instructions for Use (eIFUs) are digital versions of traditional printed IFUs that are made available to users via a website or digital portal. eIFUs are increasingly used in the medical device and diagnostic sectors to:

  • Reduce environmental impact and printing costs
  • Enable real-time updates and version control
  • Improve accessibility across geographies and languages

eIFUs are subject to stringent regulations, particularly in the EU under MDR (Annex I, Chapter III, Section 23.1) and similar requirements from the FDA and other authorities.

Sesen supports end-to-end multilingual translation of eIFUs, including formatting and delivery in regulatory-compliant digital formats. Our services include:

  • XML/HTML Translation
    Our linguists work directly in structured formats such as XML or HTML to preserve tags, code integrity, and online rendering consistency.
  • Multilingual PDF Conversion
    We localize PDFs for download and offline access in accordance with eIFU hosting requirements.
  • EU MDR and FDA eIFU Compliance
    We support clients in meeting regional regulations for electronic IFUs, including digital access requirements, device traceability, and language availability.
  • Digital QA and Hyperlink Checks
    Our QA teams validate internal links, QR codes, and language toggling to ensure a smooth end-user experience in each target language.
  • Integration with Client Platforms
    We collaborate with your regulatory and IT teams to deliver translation-ready eIFUs for CMS, product portals, or UDI-linked systems.
  • Expertise in regulated digital content translation
  • Support for over 150 languages
  • Familiarity with structured formats including XML, XLIFF, and DITA
  • Proven track record working with EU MDR, FDA, and other international regulatory frameworks
  • Scalable support for high-volume device documentation

Case Studies & Client Testimonials

Sesen has a proven track record of delivering high-quality, regulatory-compliant IFU translations for global medical device companies across a range of specialties—including in vitro diagnostics (IVD) and medical imaging systems. Our clients rely on us for precision, speed, and deep subject matter expertise.

A leading U.S.-based IVD company partnered with Sesen to translate IFUs for its molecular diagnostic kits into 25 EU and APAC languages to meet IVDR compliance. Sesen provided end-to-end language services, including translation, in-country review, XML formatting, and multilingual desktop publishing. The project was completed ahead of schedule, enabling the client to maintain its CE marking and meet regulatory submission timelines across multiple markets.

“Sesen delivered exceptional quality and attention to regulatory detail across all languages. Their ability to manage a high-volume rollout while maintaining consistency made them a critical partner in our IVDR transition.”

— Senior RA Specialist, Global IVD Manufacturer

A global medical imaging company engaged Sesen to translate and localize complex IFUs for a Class IIb radiological device, including software operation instructions and patient prep guidelines. The deliverables included PDF and eIFU XML formats, aligned with EU MDR and local LATAM health authority requirements. Sesen’s domain-specific translators and multilingual DTP team ensured all documentation met labeling and usability standards across regions.

“What impressed us most was Sesen’s fluency in both regulatory and technical language. Their team understood our device and translated its functionality clearly across regions. We consider them an extension of our global regulatory team.”

— Localization Lead, Medical Imaging Division

A leading U.S.-based IVD company partnered with Sesen to translate IFUs for its molecular diagnostic kits into 25 EU and APAC languages to meet IVDR compliance. Sesen provided end-to-end language services, including translation, in-country review, XML formatting, and multilingual desktop publishing. The project was completed ahead of schedule, enabling the client to maintain its CE marking and meet regulatory submission timelines across multiple markets.

“Sesen delivered exceptional quality and attention to regulatory detail across all languages. Their ability to manage a high-volume rollout while maintaining consistency made them a critical partner in our IVDR transition.”

— Senior RA Specialist, Global IVD Manufacturer

A global medical imaging company engaged Sesen to translate and localize complex IFUs for a Class IIb radiological device, including software operation instructions and patient prep guidelines. The deliverables included PDF and eIFU XML formats, aligned with EU MDR and local LATAM health authority requirements. Sesen’s domain-specific translators and multilingual DTP team ensured all documentation met labeling and usability standards across regions.

“What impressed us most was Sesen’s fluency in both regulatory and technical language. Their team understood our device and translated its functionality clearly across regions. We consider them an extension of our global regulatory team.”

— Localization Lead, Medical Imaging Division

These examples reflect Sesen’s ability to deliver audit-ready translations for complex medical devices in high-stakes regulatory environments—while scaling to meet global market demands.

Why Choose Sesen for IFU Translation

Sesen is a trusted partner to leading medical device companies worldwide, offering specialized IFU translation services that combine regulatory precision, linguistic accuracy, and operational scalability. Our exclusive focus on life sciences ensures a deeper understanding of industry terminology, compliance frameworks, and patient safety considerations.

Unlike generalist translation providers, Sesen works exclusively within the life sciences sector, allowing us to deliver higher-quality translations with precise medical and regulatory terminology tailored to your device category.

We have supported global IFU translation projects for Class I, II, and III devices, including implantables, diagnostics, surgical tools, and software-driven systems. Our team understands the nuances of MDR, IVDR, and FDA documentation requirements.

Sesen’s workflows are hosted on Amazon Web Services (AWS), leveraging enterprise-grade security features to protect sensitive product data and ensure compliance with client and regulatory data protection requirements.

Each project is led by a dedicated life sciences project manager, supported by in-country reviewers with medical and linguistic qualifications. This ensures consistent communication, efficient coordination, and expert oversight from kickoff to delivery.

Whether translating a single IFU or managing multi-language rollouts across 50+ markets, Sesen scales to meet your timelines. Our global linguist network and streamlined processes support urgent and high-volume translation needs without sacrificing quality.

All translations undergo rigorous quality assurance and are delivered in submission-ready formats—whether for CE marking, FDA clearance, or global regulatory filings. Our documentation and version control practices support full traceability and compliance.

Unlike generalist translation providers, Sesen works exclusively within the life sciences sector, allowing us to deliver higher-quality translations with precise medical and regulatory terminology tailored to your device category.

We have supported global IFU translation projects for Class I, II, and III devices, including implantables, diagnostics, surgical tools, and software-driven systems. Our team understands the nuances of MDR, IVDR, and FDA documentation requirements.

Sesen’s workflows are hosted on Amazon Web Services (AWS), leveraging enterprise-grade security features to protect sensitive product data and ensure compliance with client and regulatory data protection requirements.

Each project is led by a dedicated life sciences project manager, supported by in-country reviewers with medical and linguistic qualifications. This ensures consistent communication, efficient coordination, and expert oversight from kickoff to delivery.

Whether translating a single IFU or managing multi-language rollouts across 50+ markets, Sesen scales to meet your timelines. Our global linguist network and streamlined processes support urgent and high-volume translation needs without sacrificing quality.

All translations undergo rigorous quality assurance and are delivered in submission-ready formats—whether for CE marking, FDA clearance, or global regulatory filings. Our documentation and version control practices support full traceability and compliance.

Frequently Asked Questions

An Instructions for Use (IFU) document provides critical guidance on the safe and effective operation of a medical device. It typically includes product indications, usage instructions, warnings, precautions, and maintenance guidelines, and is required for regulatory submissions in most global markets.

IFU translations are required by regulatory bodies to ensure users can operate medical devices safely in their local language. Inaccurate or incomplete translations can lead to user error, compliance issues, and potential product recalls.

In the European Union, the EU MDR and IVDR mandate IFU translation into the official languages of the countries where the device is marketed. In the United States, the FDA requires clear, English-language IFUs for market clearance. Other markets, including Canada, Japan, and China, have specific language and formatting requirements.

Sesen supports IFU translation into over 150 languages, including all official EU languages, Chinese, Japanese, Korean, Arabic, Russian, and more. Our linguists are native professionals with subject matter expertise in medical devices and regulatory content.

Yes. We provide back translation, reconciliation, and dual-review processes to meet quality assurance standards for high-risk or high-stakes submissions. These services help verify translation accuracy and are often required for regulatory audits or internal QA.

Yes. Our desktop publishing (DTP) team formats IFUs according to CE marking and FDA submission requirements. We support multilingual layouts, right-to-left languages, and localization of diagrams and labeling components to maintain formatting integrity across all languages.

An Instructions for Use (IFU) document provides critical guidance on the safe and effective operation of a medical device. It typically includes product indications, usage instructions, warnings, precautions, and maintenance guidelines, and is required for regulatory submissions in most global markets.

IFU translations are required by regulatory bodies to ensure users can operate medical devices safely in their local language. Inaccurate or incomplete translations can lead to user error, compliance issues, and potential product recalls.

In the European Union, the EU MDR and IVDR mandate IFU translation into the official languages of the countries where the device is marketed. In the United States, the FDA requires clear, English-language IFUs for market clearance. Other markets, including Canada, Japan, and China, have specific language and formatting requirements.

Sesen supports IFU translation into over 150 languages, including all official EU languages, Chinese, Japanese, Korean, Arabic, Russian, and more. Our linguists are native professionals with subject matter expertise in medical devices and regulatory content.

Yes. We provide back translation, reconciliation, and dual-review processes to meet quality assurance standards for high-risk or high-stakes submissions. These services help verify translation accuracy and are often required for regulatory audits or internal QA.

Yes. Our desktop publishing (DTP) team formats IFUs according to CE marking and FDA submission requirements. We support multilingual layouts, right-to-left languages, and localization of diagrams and labeling components to maintain formatting integrity across all languages.

Get Started with Compliant IFU Translation

Ready to streamline your IFU translation process for global compliance?


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