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Medical device translation services — IFU, labeling, regulatory compliance
Accurate, Compliant Medical Device Translations for Global Success

Accurate, Compliant Medical Device Translations for Global Success

At Sesen, we understand that your medical device’s international success depends on precise, reliable documentation. From product manuals and labeling to Instructions for Use (IFUs) and technical materials, our medical device translation services go far beyond simple language conversion, they are a critical component of patient safety, regulatory compliance, and global market acceptance.

Medical device texts often include complex technical and clinical terminology, leaving no room for error. A single mistranslation can compromise device performance, endanger patient health, or trigger costly regulatory setbacks. Our linguists are trained to recognize and accurately translate these critical terms, ensuring your content retains all essential technical details,  whether it’s for IFU translation, device labeling, or regulatory submission documents.

Clear, consistent documentation fosters trust among healthcare professionals, regulatory bodies, and end users. Whether you’re launching a new device in multiple regions or updating IFUs for ongoing compliance, Sesen’s focused approach ensures your product information remains unambiguous in every target language.

With growing international demand for innovative medical technologies, the need for professional medical device translation services is steadily rising. By blending deep industry expertise with specialized translation technology, Sesen empowers medical device companies to confidently navigate global regulations, minimize risk, and deliver superior patient care across borders.

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Industry Landscape & Challenges

Industry Landscape & Challenges

Medical device manufacturers operate in a highly regulated environment marked by strict compliance requirements, complex technical documentation, and the need for culturally attuned global outreach. This section provides a concise overview of the key challenges facing the industry and highlights how Sesen’s specialized translation services help organizations meet these demands, minimize risk, and foster international growth.

Medical device manufacturers face a demanding global regulatory environment. In the United States, the FDA outlines extensive requirements for device labeling, packaging, Instructions for Use (IFUs), and premarket notifications (e.g., 510(k)). In Europe, the EU Medical Device Regulation (MDR) imposes stringent guidelines on clinical evaluation, conformity assessments, and product labeling. Other countries, such as Japan, Canada, and China, have their own evolving regulatory frameworks.

  • Strict Labeling & Documentation Guidelines:
    Every stage of the device lifecycle, design, development, manufacturing, post-market surveillance, requires clear, compliant documentation. Translations must be precise, correct in terminology, and aligned with regional regulations and standards.
  • Cross-Border Variations:
    Global submissions and registrations demand localized documentation that meets specific formatting, language, and cultural requirements. Failing to comply with any regional directive can delay market entry or lead to costly regulatory penalties.
  • Sesen’s Role:
    Sesen’s specialized medical device translation services ensure that all materials, labeling, package inserts, user guides, meet regional regulatory requirements. Our teams are well-versed in FDA, MDR, and other global standards, helping you minimize delays and achieve swift approvals.

Medical devices often involve complex scientific and engineering concepts. Effective communication requires translators and reviewers with both linguistic proficiency and deep subject matter expertise.

  • High-Level Precision:
    The accuracy of IFUs, product manuals, and technical documentation can directly affect clinical outcomes and patient safety. Translators must grasp both the technical and clinical context to ensure no critical details are lost or misinterpreted.
  • Risk of Inaccuracies:
    Even minor language errors can mislead healthcare professionals, patients, or regulators. Mistranslations could lead to device misuse, potential patient harm, or regulatory non-compliance ultimately damaging a manufacturer’s reputation and bottom line.
  • Sesen’s Role:
    At Sesen, our translation teams include subject matter experts who understand the nuances of medical, technical, and regulatory language. By combining industry experience with rigorous review processes, we deliver translations that preserve the integrity of your device information.

Embedded software is becoming increasingly prevalent in modern medical devices, from infusion pumps and diagnostic equipment to implantable devices and surgical robots. Localizing embedded software involves translating on-screen text, error messages, system prompts, and user interface elements while maintaining both technical and regulatory integrity.

  • Standards & Compliance:
    The development and maintenance of embedded software often adhere to industry standards such as IEC 62304 (Medical Device Software—Software Life Cycle Processes) and IEC 62366 (Usability Engineering). Translations for embedded software interfaces must support these requirements to ensure the product is safe, user-friendly, and fully compliant.
  • Technical Constraints:
    Space limitations on device screens, character encoding restrictions, and strict version control are common challenges. This requires precise terminology management and consistent use of abbreviations or symbols across different languages without sacrificing clarity.
  • Risk Management:
    Embedded software errors can have serious consequences, underscoring the need for robust quality assurance (QA) in localization.
  • Sesen’s Role:
    Sesen’s dedicated software localization specialists apply best practices to address UI constraints, regulatory nuances, and workflow management. Our approach ensures translated text seamlessly integrates with device software, meeting both functional and regulatory requirements.

The global medical device market continues to grow, driven by technological advancements, an aging population, and expanding healthcare access in emerging economies.

  • Multilingual Labeling & Instructions:
    Organizations looking to market devices internationally must produce accurate translations for packaging, labeling, and IFUs. Local authorities often mandate that product information be available in multiple languages, each following precise country-specific protocols.
  • Cultural & Linguistic Sensitivities:
    Beyond technical correctness, cultural nuances significantly impact user acceptance. Effective translation accounts for local conventions, idioms, and reading patterns to ensure information remains clear and accessible.
  • Time-to-Market Pressures:
    As competition increases, manufacturers strive to launch products faster across geographies. Efficient translation workflows, integrating terminology management, translation memory tools, and in-country review, help streamline processes, minimize delays, and control costs.
  • Sesen’s Role:
    Sesen’s global network of in-country linguists and life science experts enables rapid, high-quality translations that respect cultural nuances. By leveraging translation technology and best-in-class project management practices, we accelerate time-to-market while maintaining strict quality and regulatory compliance.
Sesen’s Specialized Medical Device Translations

Sesen’s Specialized Medical Device Translation Services

Sesen provides accurate, compliant medical device translation services across the full product lifecycle. We translate IFUs, labeling, technical documentation, clinical and regulatory files, and embedded software so you can register, launch, and support devices in global markets.

  • IFUs, package inserts, quick start guides, service and maintenance manuals, technical files
  • Labeling, UDI labels, cartons, pouches, eIFU and digital labeling, symbols and pictograms
  • Risk and quality documents including DHF, DMR, DHR, ISO 14971 risk reports, PMS and vigilance reports
  • Clinical documentation such as protocols, IBs, ICFs, CRFs, patient questionnaires, recruitment materials
  • FDA submissions including 510(k), De Novo, PMA
  • EU MDR and IVDR documentation for CE marking
  • UDI data and EUDAMED entries, country‑specific authority filings
  • Localized summaries of safety and clinical performance, clinical evaluation reports, post‑market reports
  • On‑device UI text, alarms, warnings, error messages, symbols and constraints
  • Companion and clinician apps, connectivity and configuration screens, release notes
  • In‑context QA to validate strings on live screens and within character limits
  • ISO 17100, ISO 9001:2015, and ISO 13485:2016 certified processes
  • Technology enabled human translation with terminology management, approved glossaries, and translation memory leverage
  • Bilingual review and change implementation, SME review for device specialties, LQA, and regulated DTP with print‑ready outputs
  • Secure workflows, audit trails, and role‑based access for regulated content across 150 languages by professional native translators
  • Marketing brochures, product websites, and campaign copy that align with approved claims
  • eLearning modules, service training decks, and field guides for global teams
  • Consistent terminology and voice across channels and regions

Medical Device Types We Translate

Medical devices, from in vitro diagnostics to advanced surgical and therapeutic systems, rely on accurate, compliant, and well-localized documentation to meet strict global regulatory requirements and ensure patient safety. At Sesen, our medical device translation services cover a wide range of device categories, helping manufacturers achieve global market access through accurate IFU translation, device labeling localization, and embedded software adaptation.

Each device type presents unique challenges in terminology, format, and compliance. With deep industry expertise and ISO-certified processes, Sesen delivers high-quality translations that support global submissions, reduce risk, and streamline approval with FDA, EU MDR/IVDR, and other regulatory bodies.

We translate IFUs, package inserts, and labeling for diagnostic reagents, test kits, and analytical instruments, ensuring clarity and compliance across multilingual markets.

Learn more about our IVD translation services

Our linguists localize documentation for MRI, CT, ultrasound, and X-ray machines, where technical accuracy in installation manuals, user interfaces, and safety instructions is essential for clinical operation.

Explore diagnostic imaging device translation solutions

From handheld surgical tools to complex robotic-assisted systems, we provide precise medical device translation services for IFUs, maintenance guides, and safety protocols to support both clinicians and compliance teams.

We translate IFUs and regulatory content for pacemakers, stents, heart valve systems, and wearable monitors — ensuring safe use and alignment with regulatory documentation requirements.

View cardiovascular translation services

We translate IFUs, surgical technique guides, and labeling for orthopedic devices including joint replacement systems, bone plates and screws, fixation hardware, and orthopedic instruments. Our medical linguists accurately convey complex anatomical and biomechanical terminology while aligning with global regulatory requirements.

Learn more about our orthopedic device translation solutions

Sesen provides professional translation for a wide range of implantable devices such as pacemakers, stents, neurostimulators, cochlear implants, and drug delivery implants. We support documentation including IFUs, surgical protocols, patient instructions, and regulatory submissions — ensuring linguistic accuracy and compliance for high-risk Class II and III medical implants.

Discover implantable device translation services

We provide translation and localization for insulin pumps, infusion systems, syringes, and wearable drug delivery devices, including multilingual IFUs and device labeling that meets both FDA and EU standards.

Our dental sector translations include orthodontic devices, implants, digital imaging systems, and patient-facing guides. All content is tailored to meet local regulations and cultural preferences.

Discover our dental device translation services

We support translations for laser surgery systems, contact lenses, diagnostic tools, and clinical evaluation materials — ensuring consistent terminology across languages and regulatory jurisdictions.

From advanced wound care products to negative pressure wound therapy systems, our translations cover IFUs, usage guides, and packaging, helping products reach global hospitals and clinics safely.

We translate materials for wheelchairs, mobility aids, wearable rehabilitation systems, and assistive technologies — adapting each element for multilingual users and healthcare providers worldwide.

Sesen provides translation support for all medical device classifications, from low-risk Class I devices to highly regulated Class II and III systems. Our workflows are tailored to meet the complexity, documentation volume, and regulatory scrutiny required at each classification level.

Quality Management & Compliance

Sesen’s unwavering commitment to quality and compliance is anchored in recognized international standards and a deep understanding of global medical device regulations. Our robust processes are designed to minimize risk, ensure accuracy, and deliver consistent results for every translated document.

  • ISO 13485 & ISO 17100:
    We align with ISO 13485 requirements for medical devices and ISO 17100 for professional translation services, ensuring a best-in-class approach to quality management and linguistic accuracy.
  • Rigorous QA & QC Processes:
    Every project undergoes multiple review stages, including linguistic validation, technical checks, and final sign-offs, to maintain impeccable standards at each step.
  • Global Regulatory Expertise:
    From MDR and FDA to other international frameworks, our teams stay current on evolving regulations and local legal requirements to guarantee fully compliant translations.
  • Continuous Staff Training:
    Ongoing professional development ensures our translators, project managers, and subject matter experts remain knowledgeable about the latest guidelines and best practices in the medical device sector.
Our Medical Device Translation Workflow

Our Medical Device Translation Workflow & Methodologies

At Sesen, our medical device translation services follow a structured, multi-step workflow designed to ensure linguistic accuracy, regulatory compliance, and consistency across all languages. Whether you need IFU translation, device labeling localization, or embedded software interface adaptation, our process is tailored to meet the strict quality and documentation standards required by global regulatory bodies such as the FDA, EU MDR/IVDR, and Health Canada.

At Sesen, our medical device translation services begin with a structured document assessment. We analyze source files such as IFUs, labeling, and technical documents to identify content types, language requirements, and regulatory implications. We also review client-specific terminology and style guides to align the translation with branding and compliance needs.

We leverage translation memory (TM), approved termbases, and industry-specific linguistic resources to maintain consistency across all medical device content. This step reduces turnaround time and ensures previously approved translations are reused intelligently.

Professional native linguists with subject matter expertise perform translations, including embedded medical software, user interfaces, and digital instructions. All translations are conducted in accordance with ISO 17100 and ISO 13485 standards.

Our medical device linguists collaborate with project managers and in-country reviewers to incorporate region-specific regulatory and technical feedback, ensuring the content aligns with FDA, EU MDR/IVDR, and other global submission standards.

Final translations undergo rigorous linguistic quality assurance using both automated QA tools and human review. For IFU translation and device labeling, we offer optional desktop publishing and layout checks to ensure print-ready and submission-ready formatting.

Certified Medical Device Translation

Certified Medical Device Translation

Sesen delivers certified medical device translations that meet the highest standards of regulatory accuracy and traceability. Our workflows are ISO 13485 and ISO 17100 certified and specifically designed to support global submissions for FDA, EU MDR, IVDR, Health Canada, and other regulatory authorities.

Certified translations are essential for 510(k) submissions, CE technical documentation, IFUs, patient-facing materials, clinical evaluation reports, and post-market surveillance documentation. Sesen ensures every deliverable is accurate, compliant, and ready for submission in multilingual formats.

Each translation is performed by qualified linguists with documented subject matter expertise in medical devices and includes complete audit trails, version control, and optional back translation. We also provide translator credentials and certification letters upon request to support notified body and agency reviews.

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Risk Mitigation & Confidentiality in Medical Device Translation

Risk Mitigation & Confidentiality in Medical Device Translation

Sesen provides secure medical device translation services designed to protect your sensitive product information at every step. Our workflows follow GDPR, HIPAA, and industry best practices for data security, with strict version control, secure file transfer protocols, and access-restricted environments. We understand the importance of confidentiality in high-stakes medical device translation, especially for regulatory submissions, product launches, and proprietary labeling materials. Every project is traceable and fully auditable, giving you complete peace of mind in international markets.

At Sesen, safeguarding your intellectual property is a top priority. We provide secure medical device translation services backed by industry-leading encryption methods, secure file transfer protocols, and stringent confidentiality agreements. These safeguards are integrated across all stages of the medical device translation process, ensuring that only authorized personnel can access your content. This commitment minimizes the risk of data breaches and reinforces trust with clients working with proprietary medical technologies.

Sesen adheres to Good Documentation Practices (GDP) and global compliance frameworks to maintain full traceability, accuracy, and accountability across every medical device translation project. From source file intake to final delivery, each step is governed by structured workflows and comprehensive audit trails. Our processes are designed to meet or exceed FDA, EU MDR/IVDR, and Health Canada requirements, helping your multilingual product documentation remain regulatory-ready and professionally managed.

Case Studies / Success Stories

Case Studies / Success Stories

Challenge: A leading laboratory equipment manufacturer needed to rapidly launch its new blood analysis machine in multiple international markets. They faced strict regulatory deadlines, extensive product labeling requirements, and a need for consistent branding across all regions.

Sesen’s Approach:

  • Comprehensive Translation Scope: We localized all critical documents, including IFUs, product manuals, and on-device software interfaces, ensuring each met local language and regulatory standards.
  • Streamlined Processes: By leveraging translation memory tools and a dedicated team of life science specialists, we reduced turnaround times without compromising quality.
  • Regulatory Coordination: Our regulatory experts aligned translations with FDA, MDR, and other pertinent global standards to minimize any risk of delayed approvals.

Results:

  • Faster Market Entry: The client met its global launch targets, saving weeks of potential delays in critical markets.
  • Regulatory Compliance: Zero non-compliance issues were reported post-launch, reinforcing the client’s reputation for safe, high-quality devices.
  • Consistent Branding: All translated materials upheld the client’s brand identity, contributing to a cohesive market presence.

Challenge: A diagnostics company planned to introduce a cutting-edge imaging tool across Asia, Europe, and Latin America. They needed carefully localized documents, ranging from technical specifications and user guides to marketing collateral, all while meeting variable regional regulations.

Sesen’s Approach:

  • In-Country Linguists: We assembled a global network of translators with medical and regulatory expertise in each target region, ensuring culturally attuned and compliant translations.
  • Multilevel Review: Each document underwent rigorous linguistic, technical, and regulatory checks, covering everything from product labeling to promotional materials.
  • Continuous Collaboration: Through regular consultations with the client’s R&D and marketing teams, we kept terminology consistent and aligned with evolving clinical data.

Results:

  • Regulatory Approval Success: The client secured timely approval in multiple countries, allowing a synchronized product release across diverse markets.
  • Reduced Costs & Errors: Leveraging our translation memory system and QA best practices minimized rework and lowered overall project expenses.
  • Market Penetration & Growth: The device’s accessible and compliant documentation helped healthcare providers adopt it quickly, boosting sales and brand credibility.

Frequently Asked Questions

Sesen translates a full range of documentation required for global medical device compliance, including Instructions for Use (IFUs), device labeling, packaging, regulatory submissions (510(k), CE Technical Files), clinical evaluation reports, installation manuals, software interfaces, and patient-facing materials.

Yes. In many countries, regulatory authorities such as the FDA, EU Notified Bodies, and Health Canada require certified translations for product registration and approval. Sesen provides certified medical translations performed by qualified linguists with documented subject matter expertise.

Our workflows are ISO 13485 and ISO 17100 certified and designed to align with regional regulatory frameworks including FDA, EU MDR, IVDR, and other country-specific standards. Each translation undergoes structured review, terminology control, and audit-traceable quality checks.

Sesen supports translation into over 150 languages, covering all major markets in North America, Europe, Asia Pacific, LATAM, and MENA. We maintain a global linguist network with in-country reviewers specialized in medical device terminology and local regulatory expressions.

Timelines vary based on document volume, target languages, and formatting requirements. A typical IFU translation into 10 languages takes approximately 5 to 7 business days. Accelerated delivery options are available for urgent regulatory or product launch timelines.

Related Services

Sesen also provides a range of specialized services that support the localization and regulatory readiness of medical devices.

Ready to streamline your medical device translations?

Request a personalized quote or schedule a consultation to discuss your specific requirements. You can also explore our detailed translation process and industry-focused services to see how we deliver precise, compliant, and culturally attuned solutions.

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