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Medical Device Translation

IFU Translation Services for Medical Devices

Sesen helps medical device and IVD companies translate, review, format, and manage Instructions for Use across languages, markets, file formats, and product revisions.

Our specialized IFU translation services combine medical device linguists, terminology governance, independent professional review, multilingual DTP, in-context QA, version control, and AI-enabled validation to support controlled global releases.

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Medical Device Specialists

Specialized translation expertise for regulated device content.

ISO-Certified Quality

ISO 17100 · ISO 9001 · ISO 13485

150+ Languages

Scalable multilingual support for global device programs.

Professional Human Review

Qualified translation and independent review supported by technology-enabled QA.

Controlled Multilingual Documentation

An IFU Is More Than the Words on the Page

Instructions for Use bring together technical instructions, safety information, product terminology, diagrams, symbols, tables, procedural sequences, and other content that must work together as a complete document.

When an IFU moves into multiple languages, each of those elements has to remain connected. A device term used in the IFU may also appear on the product label, in the software interface, in training materials, or across related technical documentation.

A translated procedure can be linguistically accurate and still become unclear if its callout, diagram, numbered step, or cross-reference is incorrect in the final layout. That is why Sesen approaches IFU translation as a controlled multilingual document workflow—not simply a text translation task.

Effective IFU localization brings linguistic accuracy, technical understanding, document production, and version control together in one coordinated process.

Technical Meaning

Operating instructions, device functions, procedures, component names, measurements, settings, and technical concepts must remain precise and understandable across languages.

Safety-Critical Information

Warnings, precautions, contraindications, limitations, risk information, and conditions of use require careful linguistic and contextual control.

Product Terminology

Device names, components, functions, UI terms, procedures, and recurring language should remain consistent across the IFU and related product content.

Document Structure

Tables, diagrams, symbols, callouts, numbered steps, cross-references, captions, and page structure all contribute to how users understand the instructions.

Version Integrity

Previously reviewed translation, approved terminology, product updates, and new source revisions must remain controlled across every required language.

From Approved Source IFU to Market-Ready Multilingual Release

Sesen manages the complete multilingual IFU workflow from source preparation through translation, professional review, production, final-format QA, and recurring updates. The process can be configured around your product, content risk, languages, file formats, existing language assets, reviewer requirements, and release process.

01

Source & Product Context

Build the right context before translation begins.

We review the approved source IFU together with the product and language resources needed to support consistent multilingual execution.

  • Previous IFU translations and translation memories
  • Product terminology, approved glossaries, and style requirements
  • Device labeling, software/UI terminology, and related technical documentation
  • Product-family references, target-market language, and prior reviewer feedback
02

Terminology Preparation

Establish consistent product language before multilingual production scales.

Sesen identifies recurring or high-impact terminology for device names, components, functions, procedures, warnings, measurements, UI terms, and approved product language.

  • Project- or client-specific glossaries
  • Approved terminology connected to translation memory
  • Terminology controls that can extend across labeling, software, and related content
03

Specialized IFU Translation

Translate the instructions with the device, audience, and intended use in mind.

Professional native-language linguists are selected for the medical, technical, and device-specific requirements of the content.

  • Technical meaning and procedural clarity
  • Safety information, measurements, and numerical content
  • Consistency with approved language and related product documentation
04

Independent Professional Review

Add a second qualified linguistic perspective before production.

A qualified second linguist can independently evaluate the target content against the source and the approved language assets.

  • Accuracy, completeness, and terminology
  • Procedural meaning, warnings, numbers, and measurements
  • Consistency, readability, and source-to-target alignment
05

Multilingual DTP & eIFU Production

Move approved translation into the required delivery format.

Sesen supports print, digital, and structured environments including InDesign, FrameMaker, Word, PDF, XML, HTML, XLIFF, and DITA.

  • Language expansion and contraction
  • Tables, diagrams, callouts, and linked graphics
  • Font compatibility, text direction, and production-ready layout
06

In-Context QA

Review the translation where users will actually see it.

Final or near-final files are checked for issues that may not be visible during standard bilingual review.

  • Truncation, overflow, missing or misplaced text
  • Tables, warnings, numbered steps, numbers, units, and symbols
  • Diagrams, cross-references, fonts, RTL behavior, and digital functionality
07

Version & Delta Control

Update what changed without unnecessarily disturbing what did not.

Translation memory and version-comparison workflows can identify source changes and reuse previously reviewed multilingual content where appropriate.

  • Focus new translation on meaningful source changes
  • Protect previously reviewed language and approved terminology
  • Carry reviewer decisions and product knowledge into future releases
08

Final Validation & Release

Deliver a controlled multilingual IFU package for the next stage of your workflow.

Final checks support the client's regulatory review, artwork approval, print production, eIFU publication, product launch, and future revision cycle.

  • Controlled language and production files
  • Controlled output for the intended downstream release workflow
  • Language assets preserved for future updates
The Outcome

A controlled multilingual IFU prepared for its intended format, audience, and downstream release process.

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Revision Control

Keep IFU Language Controlled as the Product Evolves

New device functionality, safety information, software updates, regulatory feedback, product variants, usability findings, and other changes can all create new IFU versions.

Without a controlled update strategy, small source revisions can create disproportionate multilingual work—and unnecessary variation can accumulate from one version to the next.

Establish Controlled Product Terminology

Maintain approved names for components, functions, procedures, warnings, UI elements, and other recurring language.

Reuse Previously Reviewed Translation

Use translation memory to preserve approved language rather than retranslating unchanged content unnecessarily.

Focus on What Changed

Where the files and history support it, isolate source deltas and concentrate new translation and review on meaningful changes.

Carry Reviewer Decisions Forward

Incorporate approved terminology and reviewer preferences into the language assets used for subsequent releases.

REV A Approved IFU Reviewed multilingual content
SOURCE CHANGE Delta Identified New and modified content isolated
CONTROLLED UPDATE Translate + Review Approved language preserved
REV B Multilingual Release Knowledge retained for next revision

A controlled IFU program should become more consistent and efficient as product knowledge accumulates.

Multilingual Production

Translation Isn't Finished Until the IFU Works in Its Final Format

IFUs are functional documents. Users navigate tables, warnings, numbered procedures, figures, diagrams, callouts, references, symbols, and other visual elements alongside the translated text.

Linguistic quality and document quality cannot be separated at the end of the workflow. Sesen supports multilingual layout, complex IFU elements, right-to-left and complex scripts, and final-format linguistic review so content can be evaluated in context.

Language expansion and contraction Tables, diagrams, and callouts Warnings, symbols, and measurements Cross-references and numbered procedures Right-to-left and complex scripts Final-format linguistic review
Multilingual DTP & Formatting Label Review & In-Context QA

Print IFUs, eIFUs, and Structured Content

Medical device documentation is increasingly produced across multiple channels rather than in a single printed format. Sesen supports multilingual IFU workflows across traditional print, electronic instructions for use, downloadable documents, and structured content environments.

Print & PDF IFUs

Multilingual production for traditional IFUs and user documentation across InDesign, FrameMaker, Word, print-ready PDF, source artwork, linked graphics, tables, and diagrams.

Electronic Instructions for Use

Translation and localization for multilingual PDFs, HTML, XML, digital document portals, hyperlinks, QR-linked resources, language navigation, and eIFU environments.

Structured & Reusable Content

Support for XML, XLIFF, DITA, reusable content components, CMS workflows, translation-ready structured files, and automated publishing environments.

Electronic delivery depends on the device, users, and applicable market framework.

EU eIFU rules were expanded in 2025 for a broader range of professional-use medical devices under applicable conditions. Where a professional-use device may reasonably also be used by lay persons, instructions intended for lay users remain subject to paper-delivery requirements. Sesen supports the multilingual content and production side of eIFU programs based on the requirements defined by the manufacturer.

EU MDR IFU Translation Support

IFU Translation Across Medical Device Categories

Sesen supports Instructions for Use and related product documentation across a broad range of medical-device technologies and user environments.

Diagnostic & IVD Devices

Laboratory systems, diagnostic instrumentation, IVD products, imaging and monitoring technologies, test platforms, and associated operating documentation.

Surgical & Therapeutic Devices

Surgical systems, instruments, treatment technologies, infusion and therapeutic equipment, procedural devices, and related user documentation.

Implantable & Complex Devices

Cardiovascular, orthopedic, implantable, and other complex device systems where technical precision and terminology continuity are especially important.

Software-Driven & Connected Devices

SaMD, connected medical devices, embedded interfaces, clinician software, patient-facing applications, and systems where IFU terminology must align with the software experience.

Need terminology aligned between an IFU and the device interface? Medical Device Software Localization

Built for Regulated Medical Device Documentation

IFU requirements vary by jurisdiction, device type, intended user, regulatory pathway, and market. Sesen supports the multilingual execution of manufacturer-defined requirements while remaining focused on accurate translation, terminology control, professional review, production, and quality validation.

Sesen supports multilingual implementation based on client-defined target markets and requirements; regulatory applicability and market-language determinations remain the responsibility of the manufacturer and its regulatory advisors.

EU

EU MDR & IVDR Environments

Under EU MDR, accompanying information is supplied in the official Union language or languages determined by the Member State where the device is made available. Sesen coordinates translation, terminology, formatting, revision control, and final-format QA for the client's defined EU markets and language sets.

IVD

Diagnostic & IVD Documentation

Support the scientific, technical, and user-facing content found in diagnostic instructions and related documentation.

US+

U.S. & Global Device Programs

Manage IFUs and related product information for FDA-regulated environments and defined markets across global regions.

ISO

Device Information & Symbol Context

Where relevant, workflows can accommodate manufacturer information and symbol conventions associated with standards such as ISO 20417 and ISO 15223-1, together with client-specific labeling requirements.

Regulatory Translation Services
Controlled Technology

Technology That Strengthens IFU Control

Technology is most valuable in regulated translation when it strengthens consistency, reuse, validation, and oversight. Sesen combines professional medical-device expertise with translation memory, terminology technology, automated QA, and controlled AI-enabled workflows.

Translation Memory

Identify and reuse previously reviewed multilingual content where appropriate, particularly across recurring IFU revisions.

Terminology Intelligence

Organize important product language, maintain multilingual glossaries, and monitor approved terminology across documents and releases.

AI-Assisted Validation & QA

Surface potential terminology, number, completeness, formatting, consistency, and structural issues for expert review.

Selective SesenGPT-Assisted Translation

For suitable content and language pairs, controlled AI-assisted drafting can work with translation reuse, client terminology, expert review, and validation-driven QA.

Expert Human Validation

Technology remains part of the workflow—not the final authority.

Qualified linguists review and validate regulated IFU content according to the agreed quality process, supported by terminology resources, QA tools, and prior approved translations.

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Global Program Control

One IFU Program. Multiple Markets. Consistent Execution.

Global medical device releases can involve numerous languages, product variants, source versions, reviewers, delivery formats, and overlapping market timelines.

Managing each language as an isolated translation project makes consistency harder to maintain as the program grows. Sesen provides centralized multilingual support across 150+ languages so translation, terminology, review, production, and version history can remain connected.

Centralized program management keeps source versions, terminology, reviewers, production files, and delivery schedules aligned across languages and markets.

150+ Languages

Multilingual support for established and emerging medical-device markets across Europe, the Americas, Asia-Pacific, the Middle East, and other regions.

Regional Language Adaptation

Support for appropriate regional variants, conventions, and client-approved market preferences where the program requires them.

Reviewer Coordination

Structured incorporation of feedback from regulatory teams, subject-matter experts, client reviewers, in-country stakeholders, and other designated participants.

Coordinated Multilingual Releases

Multiple languages and file types can be managed around the same approved source version for simultaneous or phased market delivery.

24 Languages Class III implantable medical device
IFU Translation in Practice

A Controlled Multilingual IFU Program for European Market Release

A U.S.-based MedTech company preparing an implantable cardiac device for Europe needed a highly technical IFU localized across 24 languages. The content included procedural instructions, safety information, clinical terminology, and device-specific language that needed to remain aligned with previously approved content and related product families.

Specialized Translation Terminology Governance Independent Review Multilingual DTP In-Context QA AI-Assisted Checks

Sesen delivered the complete 24-language IFU package in submission-ready format through a coordinated translation, review, terminology, production, and validation workflow.

Read the Class III IFU Case Study

Why Medical Device Teams Choose Sesen for IFU Translation

IFU programs require more than broad language coverage. They require a partner that understands how technical content, product terminology, professional review, document production, and recurring revisions fit together.

Medical Device Expertise

Professional linguists and reviewers selected for medical, technical, scientific, regulatory, and device-related content.

Terminology Continuity

Approved product language can be carried across IFUs, labeling, software, technical documentation, training, and subsequent versions.

Independent Professional Review

Structured second-linguist review provides an additional quality layer for regulated and safety-sensitive documentation.

Multilingual Production Expertise

Translation, review, DTP, structured content support, eIFU production, and final-format QA can be coordinated within one workflow.

In-Context Validation

Translated content can be evaluated inside the actual multilingual layout, not only within translation files.

Revision & Program Control

Translation memory, terminology, reviewer feedback, previous translations, and version comparison help maintain continuity as IFUs evolve.

From the first translated segment through the final multilingual release, Sesen helps medical device teams maintain control of the IFU as a complete regulated document.

Connected Support for Medical Device Content

IFUs rarely exist in isolation. Sesen provides specialized multilingual support across the broader medical-device content ecosystem.

Medical Device Translation Services

Translation and localization across the device lifecycle, including technical documentation, IFUs, labeling, software, training, and post-market content.

Medical Device Labeling Translation

Multilingual support for device labels, packaging, warnings, safety information, product identification, and related labeling content.

Label Review & In-Context QA

Final-layout linguistic validation for IFUs, labels, packaging, and other regulated content after translation enters production.

Medical Device Software Localization

Localization for device interfaces, SaMD, connected technologies, clinician software, patient applications, and related digital content.

Regulatory Translation Services

Specialized translation for regulatory submissions, technical documentation, authority communications, quality content, and lifecycle updates.

Regulatory Submission Formatting

Multilingual formatting, layout, table review, file preparation, and production support for regulated documentation.

IFU Translation Services FAQ

Answers to common questions about multilingual Instructions for Use, revision control, DTP, eIFU production, professional review, and global device programs.

What are IFU translation services?

IFU translation services cover the specialized translation and localization of medical device Instructions for Use from a source language into one or more target languages. A complete workflow may include source review, terminology preparation, professional translation, independent linguistic review, multilingual desktop publishing, eIFU or structured-content production, in-context QA, version control, and final file validation. For regulated device content, these controls help keep terminology, instructions, warnings, document structure, and revisions consistent across languages.

What types of medical device IFUs does Sesen translate?

Sesen supports IFUs for a broad range of medical devices and IVD products, including diagnostic and monitoring systems, laboratory and testing equipment, surgical and therapeutic devices, implantable devices, orthopedic products, connected devices, SaMD, and other software-driven technologies. We also support related user manuals, product documentation, electronic IFUs, package inserts, and other device content that shares terminology with the IFU.

How many languages does Sesen support for IFU translation?

Sesen supports medical device translation and localization across 150+ languages. For multinational IFU programs, Sesen can coordinate regional variants, terminology, translation memories, reviewers, file production, and simultaneous or phased releases within a centralized workflow.

How does Sesen maintain terminology consistency across IFU revisions?

Sesen can establish and maintain client- and product-specific terminology resources covering device names, components, functions, procedures, warnings, UI terminology, and other recurring language. These resources work together with translation memory, previous approved translations, client references, reviewer feedback, and QA to help maintain consistency across new versions and related device content.

Can Sesen translate an IFU update without retranslating the entire document?

Yes, where suitable source files and translation history are available. Sesen can use translation memory and version-comparison workflows to identify new or changed source content and reuse previously translated material where appropriate. The exact workflow depends on the source format, previous language assets, revision history, and client quality requirements.

Does Sesen provide multilingual DTP for IFUs?

Yes. Sesen supports multilingual desktop publishing and formatting across common IFU production environments, including Adobe InDesign, FrameMaker, Microsoft Word, PDF, structured files, and other formats. DTP workflows can account for text expansion and contraction, fonts, tables, diagrams, callouts, right-to-left languages, line breaks, page flow, and other language-specific production requirements.

Does Sesen perform in-context QA after IFU formatting?

Yes. In-context QA reviews translated content in the actual formatted IFU rather than only in a bilingual translation environment. This can identify issues such as truncated text, missing content, incorrect line breaks, misplaced translations, broken tables, symbol or number problems, right-to-left rendering issues, and discrepancies between translated text and its associated diagram or procedural step.

Does Sesen support electronic Instructions for Use?

Yes. Sesen supports multilingual eIFU workflows including translation and localization for digital PDFs, XML, HTML, structured content, hyperlinks, QR-linked resources, and online document environments. EU eIFU rules were expanded in 2025 for a broader range of professional-use medical devices under applicable conditions; where a professional-use device may reasonably also be used by lay persons, instructions intended for lay users remain subject to paper-delivery requirements. The appropriate delivery approach depends on the product, users, jurisdiction, and the manufacturer's regulatory determination.

What languages are required for medical device IFUs in the European Union?

The required language set depends on the countries in which the device will be made available and the applicable requirements in those markets. Under EU MDR, accompanying information must be supplied in the official Union language or languages determined by the Member State where the device is made available to the user or patient. Sesen supports translation, review, formatting, and QA once the manufacturer has defined its target markets and required language set.

Does Sesen support EU MDR and IVDR IFU translation?

Yes. Sesen supports medical device and IVD organizations with multilingual IFU translation for programs operating in EU MDR and IVDR environments. Services can include terminology preparation, specialized translation, independent professional review, multilingual DTP, eIFU support, in-context QA, version control, and coordinated language delivery. Regulatory applicability and market-language determinations remain the responsibility of the manufacturer and its regulatory advisors.

Does Sesen provide independent review for regulated IFUs?

Yes. Depending on the required quality workflow, Sesen can assign a qualified second linguist to independently review the translated IFU against the source. The review can cover accuracy, completeness, terminology, technical meaning, warnings, procedures, measurements, consistency, readability, and compliance with approved client language assets.

Does Sesen use AI for IFU translation?

Sesen uses AI selectively within controlled multilingual workflows. For appropriate content and language pairs, SesenGPT can support translation drafting, terminology processing, approved translation reuse, and validation-driven QA. Professional medical linguists review and validate the content according to the agreed quality workflow. Content type, intended use, risk profile, language pair, previous translations, client terminology, and quality requirements help determine the appropriate approach.

Can Sesen support an ongoing multilingual IFU program?

Yes. Sesen can support recurring IFU releases across product versions, languages, markets, and file formats. Translation memories, terminology assets, reviewer feedback, previous multilingual content, workflow requirements, and production knowledge can be maintained across the program to improve continuity from one release to the next.

Support Your Next Multilingual IFU Release

Whether you are preparing an IFU for a new medical device launch, updating an existing product, expanding into additional markets, moving to electronic instructions for use, or managing recurring revisions across a global device portfolio, Sesen can build the multilingual workflow around your content, languages, formats, reviewers, and release requirements.

Medical device expertise · terminology governance · independent professional review · multilingual DTP · in-context QA · controlled AI-enabled workflows · version continuity · 150+ languages
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