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.
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.
Regulatory 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.
Risk Mitigation
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.
Improved Usability and Safety
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.
Accelerated Global Market Entry
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.
Life Sciences-Only Focus
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.
ISO-Certified Workflows
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.
Domain-Specific Linguists
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.
Regulatory and Linguistic Review
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.
Multilingual Desktop Publishing (DTP)
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.
Implantable and Non-Implantable Device IFUs
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.
Surgical Instruments and User Manuals
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.
Software-Driven Device Instructions
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.
eIFUs (Electronic Instructions for Use)
We provide multilingual translation and XML formatting support for eIFUs, helping device manufacturers meet digital documentation requirements across regulated markets.
Multilingual Package Inserts and Patient Leaflets
Our team translates and formats patient-facing materials that accompany medical devices, ensuring they are culturally adapted and medically accurate for global audiences.
Companion Diagnostic IFUs
Sesen delivers regulatory-compliant translations for companion diagnostic devices, ensuring alignment with associated therapeutic products and supporting clinical interpretation.
Combined Labeling + IFU Documents
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.
EU Medical Device Regulation (MDR)
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.
In Vitro Diagnostic Regulation (IVDR)
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.
U.S. FDA Labeling and UDI Requirements
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.
International Market Compliance
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.
Standardized Medical Terminology
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.
Document Analysis & Terminology Extraction
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.
Expert Linguist Assignment
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.
Translation, Review, and Validation
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.
Multilingual Desktop Publishing (DTP)
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.
Quality Assurance & Linguistic QA (LQA)
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.
Final Delivery with Optional Consulting
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.
Major European Languages
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.
Asian Languages
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.
Middle Eastern Languages
We offer expert IFU translations in Arabic, Hebrew, and Turkish, ensuring alignment with medical device regulations and labeling expectations in MENA markets.
Latin American Languages
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.
Other Global Languages
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.
Translation Memory and Glossary Management
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.
System Integration Capabilities
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.
Structured Content and Format Support
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.
Machine Translation + Human Post-Editing (MTPE)
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.
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.
Life Sciences-Only Focus
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.
Proven Experience in Medical Devices
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.
Secure, Cloud-Based Translation Environment
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.
Dedicated Project Management
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.
Scalable Global Resources
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.
Audit-Ready Deliverables
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.
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.
Case Study: Multilingual IFUs for IVD Manufacturer
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.
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— Senior RA Specialist, Global IVD Manufacturer
Case Study: Imaging Device IFUs for EU and LATAM Markets
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.
” src=”cid:image002.png@01DB9F24.34AB1D30″ alt=”image002.png” v:shapes=”Straight_x0020_Connector_x0020_4″ class=”Apple-web-attachment Singleton” style=”width: 0.0166in; height: 0.575in; opacity: 1;”>“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.
Frequently Asked Questions (FAQ)
Do you support eIFU translation and XML outputs?
Yes. Sesen provides full support for electronic IFUs (eIFUs), including translation, localization, and delivery in XML and other structured formats. We work with regulatory-compliant eIFU platforms and can align content with device-specific XML schemas and digital labeling requirements.
Can you help us prepare for EU MDR compliance?
Absolutely. Sesen’s translation workflows are fully aligned with EU MDR 2017/745 and IVDR 2017/746. We ensure that all IFU translations meet language, readability, and labeling requirements for CE marking and notified body review. Optional regulatory consulting is also available for document readiness.
How do you ensure medical terminology accuracy?
We use subject matter experts, approved client glossaries, and translation memory (TM) tools to maintain consistent and accurate terminology across all target languages. Each project includes a bilingual review and, when needed, in-country validation by medical professionals.
Do you offer rush services for urgent submissions?
Yes. Sesen offers expedited IFU translation services for time-critical regulatory filings, product launches, or corrective actions. We maintain scalable resources and follow a structured process to preserve quality even on accelerated timelines.
Can you manage multi-language rollouts for product families?
Yes. We specialize in managing multilingual IFU translation projects across large product lines or related device families. Our project managers coordinate language workflows, version control, and formatting to ensure consistency and regulatory alignment across all markets.
What languages do you support for IFU translation?
We support over 150 languages, including all official EU, APAC, LATAM, and MENA market languages. Our linguists are native speakers with medical device expertise, and we assign language pairs based on region-specific regulatory and linguistic requirements.
