Client Portal

Medical Devices

Medical Device Translation Services

Sesen helps medical device companies translate and localize regulated content across the product lifecycle — from development and clinical evaluation through regulatory submission, product launch, software deployment, and post-market support.

Our specialized medical device translation services support IFUs, labeling and packaging, technical documentation, regulatory materials, software and SaMD, clinical content, training, and post-market communications with terminology-controlled, quality-focused workflows built for global life sciences organizations.

CONTACT SALES REQUEST A QUOTE
Life Sciences Specialization
ISO 17100 · ISO 9001 · ISO 13485
150+ Languages
Professional Human Review

Regulated Device Content

Translation Built for Regulated Medical Device Content

Medical device translation is not the same as general technical translation. Device content often sits at the intersection of engineering, clinical evidence, regulatory requirements, product safety, usability, software, and patient or healthcare-professional communication.

A translated term may appear in an IFU, device label, software interface, training module, technical document, and post-market communication. A warning may need to remain precise across multiple formats and revisions. A software update may introduce new strings that must remain aligned with approved terminology already used elsewhere in the product ecosystem.

Sesen helps medical device organizations manage this complexity with specialized linguistic expertise, terminology governance, translation memory, professional review, multilingual quality assurance, and controlled version-management workflows.

Technical Precision

Product specifications, operating instructions, warnings, procedures, measurements, device functions, and technical concepts must remain accurate and understandable across languages.

Regulatory Context

IFUs, labeling, software content, technical documentation, clinical evidence, and post-market materials often sit inside broader regulated product and quality workflows.

User & Patient Safety

Instructions, warnings, contraindications, precautions, alarms, and procedural language must communicate clearly to the people who use, operate, maintain, or interact with the device.

Product Terminology

Approved terminology needs to remain consistent across product families, markets, documents, software releases, and successive content versions.

One device. Hundreds of multilingual content touchpoints.

Sesen helps keep them connected.

Medical Device Content Across Every Critical Workflow

Sesen supports multilingual content throughout medical device development, regulatory review, market authorization, commercialization, product use, and ongoing lifecycle management. Rather than treating each file as an isolated translation project, we help teams maintain terminology and content continuity across related documents, systems, product versions, and markets.

Instructions for Use & User Guidance

Accurate, readable IFUs help clinicians, patients, technicians, caregivers, and other users understand how a device is intended to be operated, handled, maintained, and used safely.

  • Instructions for Use (IFUs) and DFUs
  • User and operator manuals
  • Quick-reference and quick-start guides
  • Installation and maintenance instructions
  • Warnings, precautions, and contraindications
  • Electronic Instructions for Use (eIFU)
  • Recurring IFU revisions and updates
Explore IFU Translation Services

Medical Device Labeling & Packaging

Sesen helps keep critical product information aligned with device documentation and approved terminology across tightly constrained multilingual layouts.

  • Device labels and packaging
  • Cartons and package inserts
  • Safety information and warnings
  • Product claims and handling information
  • UDI-related labeling content
  • Digital labeling
  • Market-specific labeling updates
Explore Labeling Translation Services

Regulatory & Technical Documentation

Support multilingual documentation across development, conformity assessment, registration, quality management, change control, and ongoing market support.

  • Technical documentation and technical files
  • Regulatory submission materials
  • Device descriptions and specifications
  • Risk management documentation
  • Quality system content
  • Verification and validation materials
  • Regulatory correspondence and product updates
Explore Regulatory Translation Services

Software, SaMD & Connected Devices

Localize software-driven device experiences while preserving context, terminology, interface constraints, and alignment with physical and digital product documentation.

  • Device user interfaces
  • Embedded software
  • Software as a Medical Device (SaMD)
  • Connected medical devices
  • Mobile medical applications
  • Clinician dashboards
  • Cybersecurity and software lifecycle documentation
  • Alerts, help content, and release materials
Explore Medical Device Software Localization

Clinical, Safety & Human Factors Content

Support evidence and documentation connecting device performance with intended users, clinical environments, product safety, and usability.

  • Clinical investigation materials
  • Clinical evaluation and performance content
  • Usability studies and human factors
  • Risk and safety documentation
  • Patient and user materials
  • Investigator and site documentation
  • Questionnaires and study-related instruments
Explore Clinical Trial Translation Services

Training, Service & Product Support

Extend approved product language into training and support materials used by healthcare professionals, technicians, service teams, and other device users.

  • Product and HCP training
  • Technical training and eLearning
  • Installation materials
  • Service documentation
  • Troubleshooting content
  • Technical bulletins
  • Multimedia and audiovisual training

Post-Market & Lifecycle Content

Manage multilingual communication after launch as evidence, product information, software, labeling, and safety content evolve over time.

  • Post-market surveillance (PMS)
  • Post-market clinical follow-up (PMCF)
  • Complaint documentation
  • Field and safety communications
  • Corrective-action content
  • Revised IFUs and labeling
  • Software and product lifecycle updates

Lifecycle Continuity

Translation Across the Medical Device Lifecycle

Multilingual requirements do not begin with a final IFU and end at product launch. Device content evolves continuously as products move from development into clinical and regulatory programs, commercialization, and ongoing market support.

01

Product Development

Build multilingual readiness early by establishing consistent product language before it spreads across downstream content.

  • Risk and usability documentation
  • Design and product specifications
  • Early technical documentation
  • Software and interface content
  • Terminology development
Establish consistent device terminology early.
02

Clinical & Regulatory

Support the documentation used to evaluate, substantiate, document, and communicate device safety and performance.

  • Clinical investigation materials
  • Clinical evaluation documentation
  • Performance documentation
  • Regulatory submissions
  • Technical files and quality content
Maintain meaning as the regulated product record develops.
03

Labeling & Launch

Coordinate the multilingual content users and markets encounter when the product is commercialized.

  • IFUs and DFUs
  • Device labeling and packaging
  • Software and UI
  • eIFU
  • Training and product support
Synchronize languages, files, reviewers, and release schedules.
04

Post-Market Support

Maintain multilingual consistency as products, evidence, requirements, and safety information evolve after launch.

  • PMS and PMCF materials
  • Complaints and field communications
  • Safety and corrective-action updates
  • Updated IFUs and labels
  • Software and product revisions
Update what changed while protecting approved content.

Where Accuracy, Consistency and User Experience Converge

IFUs, labeling, and device software are high-control environments where linguistic quality, regulatory context, usability, formatting, and version management must work together.

IFU Translation

Instructions That Stay Accurate Across Languages and Revisions

IFUs combine technical procedures, safety information, device terminology, diagrams, measurements, tables, warnings, and user-facing instructions in a single controlled document.

  • Technical meaning and procedural clarity
  • Warnings and precautions
  • Approved terminology
  • Cross-reference integrity
  • Version alignment
  • Multilingual layout quality
  • Print and eIFU readiness
Explore IFU Translation Services

Labeling & Packaging

Translation That Works in the Final Layout

Labels and packaging place critical information into highly constrained layouts where text expansion, symbols, product identifiers, market language, and artwork all interact.

  • Translation and professional review
  • Terminology harmonization
  • Multilingual DTP
  • Artwork adaptation
  • In-context linguistic QA
  • Version comparison and final-format checks
Explore Labeling Translation Services

Medical Device Software

Context-Aware Localization for UI, SaMD and Connected Devices

A short source string can mean different things depending on the screen, workflow, user role, device state, or character limit. Software language must work in the interface and remain aligned with the product ecosystem.

  • UI and embedded software strings
  • SaMD and connected-device experiences
  • Context and character limits
  • Terminology alignment
  • Software lifecycle, release, and update workflows
  • In-context review
Explore Medical Device Software Localization
Connected content requires connected terminology. One product term should not become five different translations because it appears in five different systems.

Enterprise Content Control

Terminology and Version Control Across Every Product Touchpoint

Medical device content changes continuously. An IFU is revised. A warning is updated. A new software release introduces additional strings. Packaging changes. Reviewer feedback modifies approved language. A new product model reuses content from an existing family.

Without centralized terminology and translation assets, small changes can introduce inconsistencies across languages and documents. Sesen helps medical device organizations manage recurring multilingual content with structured terminology, translation memory, reviewer feedback, and controlled version workflows.

IFUsLabelingSoftwareTechnical DocumentationTrainingPost-Market

Approved Device Terminology

Create and maintain product-specific glossaries for device names, components, functions, procedures, warnings, UI terminology, technical concepts, and recurring regulated language.

Translation Memory

Reuse previously translated and reviewed language across recurring content, product families, and future updates where appropriate.

Version & Delta Management

Identify changed source content and focus translation and review on affected segments while protecting unchanged approved language.

Reviewer Feedback

Capture approved client and in-country reviewer decisions so they become reusable knowledge rather than isolated comments in individual files.

Quality Controls Designed for Regulated Content

Medical device translation requires more than a final spell-check. Sesen combines specialized linguistic expertise, ISO-certified processes, terminology controls, professional review, automated QA, and project documentation to support regulated and safety-sensitive device content.

Our quality approach can be adapted to the content type, intended audience, project requirements, and level of risk.

01

Content & Workflow Analysis

Review source content, file formats, language requirements, terminology, translation memories, reference materials, timelines, and reviewer expectations.

02

Linguist Assignment

Assign professional native-language linguists with relevant medical, scientific, technical, regulatory, or device-domain experience.

03

Terminology Preparation

Extract, align, or confirm key terminology before translation, particularly for recurring product concepts and safety-sensitive language.

04

Translation

Translate using approved terminology, relevant references, translation memory, and appropriate technology.

05

Professional Review

Qualified reviewers evaluate accuracy, meaning, terminology, readability, consistency, and suitability for the intended audience and content type.

06

Linguistic & Automated QA

Quality checks help identify terminology, numbers, missing content, inconsistent translations, tags, formatting, and version discrepancies.

07

Formatting & In-Context Review

For IFUs, labels, software, packaging, and other layout-sensitive content, review can extend into the final environment.

08

Final Validation & Delivery

Incorporate approved feedback, perform final checks, and deliver the required multilingual files and supporting project documentation.

ISO-Certified Quality Infrastructure

Sesen's quality infrastructure supports multilingual life sciences programs with professional review, documented controls, secure infrastructure, and medical-device-relevant quality practices.

View Quality, Compliance & Security
ISO 17100 — Translation Services ISO 9001:2015 — Quality Management ISO 13485:2016 — Medical Device Quality Management Secure AWS-Hosted Infrastructure Professional Native Medical Linguists Controlled Multilingual Workflows

SesenGPT

AI-Assisted Workflows with Professional Human Validation

AI can improve the efficiency and visibility of multilingual medical-device workflows — but regulated content requires judgment about where and how AI should be applied.

For suitable content, SesenGPT and related AI-enabled technologies can support translation, terminology, consistency checking, repetitive-content processing, and multilingual QA. The objective is not uncontrolled automation.

AI is a workflow advantage. Professional medical-device expertise remains central to quality.
Explore SesenGPT

Selective AI Application

Sesen evaluates content type, risk, language pair, terminology maturity, translation history, intended use, and client requirements before determining how AI should be used.

Terminology-Guided Translation

Approved terminology, translation memory, product references, and existing multilingual assets can help guide AI-assisted output before professional review.

Expert Human Review

Professional medical linguists evaluate meaning, technical terminology, readability, warnings, instructions, contextual accuracy, and market-specific language.

AI-Assisted QA

Automated checks can help surface terminology inconsistencies, number mismatches, missing content, formatting issues, and cross-document differences.

Final Human Validation Final deliverables remain subject to the professional review and validation required by the agreed workflow.

Supporting Medical Devices Across Product Categories

Sesen provides translation and localization support across a broad range of medical-device technologies and product environments while maintaining the same core focus on controlled terminology, expert review, and lifecycle continuity.

Diagnostic & Monitoring Devices

IVD, laboratory and diagnostic systems, patient monitoring technologies, diagnostic imaging, ophthalmic devices, testing platforms, and related software and documentation.

Surgical & Therapeutic Devices

Surgical systems, instruments, therapeutic equipment, procedural technologies, and related IFUs, labeling, technical content, software, and training.

Implantable & Orthopedic Devices

High-sensitivity documentation for implantable, cardiovascular, orthopedic, and other device systems where precise terminology and user instructions are especially important.

Digital & Connected Medical Devices

SaMD, connected devices, digitally enabled medical technologies, applications, clinician interfaces, patient-facing software, and AI-enabled device ecosystems.

Whatever the product category, the underlying requirement is similar: the multilingual content should remain connected to the same approved product language throughout the lifecycle.

Global Program Delivery

One Device Program. Multiple Markets. Consistent Execution.

Global medical device launches can involve dozens of languages, multiple document types, overlapping regulatory timelines, software releases, product variants, reviewers, and successive content updates.

Sesen provides centralized multilingual program support across 150+ languages, helping medical device organizations coordinate global and regional requirements without losing control of terminology, versioning, and quality.

Explore Life Sciences Translation Services

150+ Languages

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

Regional Language Adaptation

Support appropriate regional terminology, language variants, market conventions, and approved client preferences.

Reviewer Coordination

Structure feedback from client teams, subject-matter experts, in-country reviewers, and other designated stakeholders.

Simultaneous Multilingual Releases

Coordinate multiple languages and file types around launches, labeling updates, software releases, and post-market communications.

Recurring Programs

Maintain terminology, translation memory, reviewer history, and workflow knowledge across ongoing product families and content updates.

A global device program should become easier to manage as multilingual knowledge accumulates — not restart with every new file.

Program Proof

Medical Device Translation in Practice

Two representative medical-device programs show how terminology governance, multilingual production, and in-context validation work in practice.

IVD Labeling & Packaging 15 Languages

Coordinated Labeling Across EU, APAC and LATAM Markets

A global manufacturer of in-vitro diagnostic systems engaged Sesen to support a multilingual labeling program spanning 15 languages. The program included IFUs, carton labels, blister-pack content, and safety information across multiple product configurations.

Terminology HarmonizationMultilingual DTPVersion ControlIn-Context QA

The workflow aligned IFU and packaging content across markets while supporting coordinated multilingual delivery for the global product-line expansion.

Read the IVD Labeling Case Study
Class III Medical Device IFUs 24 EU Languages

Submission-Ready IFUs for an Implantable Cardiac Device

A U.S.-based MedTech company preparing an implantable cardiac device for European market authorization needed highly technical IFUs localized into 24 EU languages while maintaining terminology consistency across related product families and legacy documentation.

Specialized LinguistsTerminology ControlMultilingual LayoutFinal In-Context QA

The resulting 24-language IFU package was delivered in submission-ready format, and the client's notified body approved the translations without revisions.

Read the Class III IFU Case Study

A Specialized Partner for Global Medical Device Programs

Medical-device organizations need more than language coverage. They need a multilingual partner that understands how regulated content connects across people, products, systems, and time.

Medical Device Expertise

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

Lifecycle Continuity

Translation support from development and clinical evaluation through labeling, software deployment, launch, and post-market updates.

Terminology Governance

Structured terminology, translation memory, and reviewer feedback help maintain consistency across documents, languages, and product versions.

Quality-Controlled Workflows

ISO-certified processes, professional review, QA, formatting checks, and project documentation support regulated multilingual operations.

Technology with Oversight

SesenGPT, translation memory, terminology technology, and automated QA strengthen workflows while professional expertise remains central.

Global Program Management

Centralized coordination across 150+ languages, file types, markets, reviewers, releases, and recurring content programs.

Related Services

Medical-device translation frequently intersects with other regulated content disciplines. Sesen's broader life sciences specialization helps multilingual programs connect related workflows rather than manage each requirement in isolation.

View All Sesen Services

Regulatory Translation Services

Translation for regulatory submissions, technical documentation, quality content, authority correspondence, and regulated product workflows.

Clinical Trial Translation Services

Support for device clinical investigations, study documentation, patient-facing materials, site content, and clinical evidence.

Medical & Scientific Translation Services

Specialized translation for scientific, medical, research, technical, medical-affairs, publication, and education content.

Life Sciences Translation Services

Explore Sesen's broader support for pharmaceutical, biotechnology, medical device, CRO, healthcare, and regulated life sciences organizations.

Medical Device Translation Services FAQ

Answers to common questions about IFUs, labeling, software localization, terminology control, version management, AI-assisted workflows, quality, and global language support.

What are medical device translation services?

Medical device translation services cover the translation and localization of multilingual content used throughout the medical-device lifecycle. This can include Instructions for Use, labeling, packaging, software interfaces, technical documentation, clinical and regulatory materials, risk and safety content, training, and post-market communications. Unlike general technical translation, medical-device translation often requires specialized terminology, version control, professional review, formatting validation, and alignment across interconnected regulated content.

Does Sesen translate IFUs and medical device labeling?

Yes. Sesen supports translation and localization of IFUs, DFUs, user manuals, device labels, packaging, package inserts, warnings, precautions, safety information, eIFUs, and related user documentation. Workflows can incorporate terminology management, translation memory, professional medical-device review, multilingual DTP, in-context QA, and version-controlled updates.

Can Sesen localize medical device software and SaMD?

Yes. Sesen supports localization for embedded device interfaces, Software as a Medical Device, connected devices, mobile applications, clinician dashboards, patient apps, digital-health platforms, alerts, help content, and software release materials. Software localization can include terminology management, contextual review, character-limit considerations, linguistic QA, and alignment with corresponding terminology used in IFUs, labeling, and other product documentation.

How does Sesen maintain terminology consistency across device documentation?

Sesen can establish and maintain product-specific terminology resources that capture approved device names, components, functions, warnings, procedures, UI terms, and other recurring language. These resources work together with translation memory, client references, reviewer feedback, and QA processes to help keep terminology consistent across IFUs, labels, software, technical documentation, training, and post-market content.

How does Sesen manage updated IFUs, labels, and product revisions?

For recurring content, Sesen can use translation memory and version-comparison workflows to identify source changes and reuse previously translated and approved content where appropriate. This delta-based approach helps teams focus translation and review effort on what has actually changed while reducing unnecessary variation in unchanged content. Reviewer feedback and updated terminology can also be incorporated into future versions.

Does Sesen use AI for medical device translation?

Sesen applies AI-assisted translation selectively. Before determining the appropriate workflow, we consider content type, risk profile, language pair, existing terminology, translation history, client requirements, and intended use. For suitable content, SesenGPT and AI-assisted QA can help improve consistency and efficiency. Professional medical linguists review and validate content according to the agreed quality workflow. For regulated medical-device content, Sesen treats AI as controlled workflow technology rather than a replacement for qualified professional review.

What quality controls does Sesen use for regulated medical device content?

Depending on project requirements, Sesen's workflows can include source-content analysis, terminology preparation, qualified linguist assignment, translation, professional review, linguistic QA, automated QA, formatting checks, in-context review, client reviewer coordination, and final validation. Sesen maintains ISO 17100, ISO 9001:2015, and ISO 13485:2016 certifications as part of its quality infrastructure for multilingual life sciences services.

How many languages does Sesen support for medical device translation?

Sesen supports medical-device translation and localization in 150+ languages, including multilingual programs spanning Europe, North America, Latin America, Asia-Pacific, the Middle East, and other global markets. For multinational programs, Sesen can coordinate language variants, terminology, reviewers, translation memories, file production, and simultaneous or phased releases through a centralized workflow.

Bring Your Medical Device Content to Global Markets with Confidence

From an early terminology strategy to a multilingual IFU release, a localized software interface, or a recurring global labeling program, Sesen helps medical device organizations manage multilingual content with the specialization, controls, and continuity regulated products demand.

Medical-device expertise · terminology governance · professional human review · ISO-certified quality processes · controlled AI-enabled workflows · scalable multilingual delivery

CONTACT SALES REQUEST A QUOTE