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Why Accurate Translation Matters for Orthopedic Devices

Why Accurate Translation Matters for Orthopedic Devices

Orthopedic devices play a critical role in restoring mobility and improving quality of life for millions of patients worldwide. From joint replacement systems and trauma fixation hardware to spinal implants and orthopedic surgical tools, these products require precise and compliant documentation to ensure safe and effective use across global markets.

Accurate translation of orthopedic content is essential due to the complexity of anatomical terminology and biomechanical concepts. Even minor errors in translating surgical technique guides, IFUs, or labeling can lead to clinical misunderstandings, increased regulatory scrutiny, or patient safety risks.

Global health authorities including the FDA, European Commission (EU MDR), and Japan’s MHLW require translated materials that meet strict standards for clarity, consistency, and technical accuracy. Noncompliance can result in delayed approvals, product recalls, or market access restrictions.

Sesen specializes exclusively in life sciences translation. Our professional native medical linguists combine subject matter expertise in orthopedics with deep knowledge of international regulatory requirements. We deliver linguistically accurate and fully compliant translations to support successful orthopedic product launches and lifecycle maintenance worldwide.

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Orthopedic Device Types We Support

Orthopedic Device Types We Support

Sesen provides expert translation services for a wide range of orthopedic medical devices used in surgical, trauma, and rehabilitation settings. Our team supports global manufacturers with linguistically precise and regulatory-compliant translations for the following device categories:

Translation of product labeling, surgical protocols, and IFUs for hip, knee, and shoulder arthroplasty devices, including cemented and cementless implants.

Accurate localization of documents for bone plates, locking screws, intramedullary nails, and external fixation systems used in orthopedic trauma procedures.

Technical translation of content related to spinal fusion devices, interbody cages, pedicle screws, and vertebral fixation systems.

Translation of user manuals and surgical instructions for arthroscopic shavers, graspers, punches, and powered surgical tools.

Multilingual support for materials used in bone regeneration and void filling, including demineralized bone matrix (DBM), ceramics, and polymer-based grafts.

Specialized translation of IFUs and patient guides for intramedullary limb lengthening nails, external fixators, and distraction osteogenesis systems.

Regulatory-compliant translation of labeling and technical documentation for bone morphogenetic proteins (BMPs), stem cell therapies, and growth factor products.

Localization of interface text, training content, and procedural documentation for robotic orthopedic systems used in joint and spine surgeries.

Our orthopedic translation solutions are tailored to meet the complex needs of medical device manufacturers, ensuring accurate terminology, regulatory compliance, and global readiness.

Documents We Translate for Orthopedic Devices

Sesen delivers high-accuracy translations for all documentation required throughout the orthopedic device lifecycle. From regulatory submissions to surgeon training content, we ensure that every translated asset meets the linguistic, technical, and formatting standards demanded by global health authorities.

Precise and regulatory-aligned translations of orthopedic IFUs, including safety warnings, procedural steps, indications, contraindications, and sterilization instructions.

Localization of detailed procedural guides for orthopedic surgeons, including device assembly, surgical workflow, instrumentation, and intraoperative tips.

Clear, culturally appropriate translations of patient-facing content such as implant descriptions, post-op care guidance, and consent documentation.

Multilingual labeling and packaging translation services that comply with regional standards for device identification, traceability, and use instructions.

Translation of documentation required for market approvals including 510(k) files, CE marking dossiers, PMDA applications, and Health Canada submissions.

Translation of CERs and associated clinical data used to demonstrate device safety, performance, and compliance under EU MDR and other frameworks.

Marketing localization for brochures, digital campaigns, and sales presentations while maintaining scientific accuracy and brand tone.

Professional translation of interactive training content, onboarding materials, and technical modules for internal and external orthopedic stakeholders.

Our translations are performed by professional native linguists with orthopedic expertise and reviewed through ISO 17100-compliant QA workflows to ensure global compliance and clinical precision.

Compliance with Global Regulatory Standards

Compliance with Global Regulatory Standards

Orthopedic device manufacturers face increasingly stringent regulatory requirements when launching products in international markets. Accurate translation is not only essential for clinical safety but is also a regulatory obligation enforced by health authorities worldwide.

Sesen provides orthopedic translation services that align with the latest global standards and regional directives, ensuring your multilingual documentation supports full market authorization and post-market compliance.

We support translation and localization requirements for key regulatory frameworks, including:

Compliant translations for Instructions for Use, labeling, and technical documentation under the European Union Medical Device Regulation and In Vitro Diagnostic Regulation.

Translation of labeling and patient information to meet the U.S. Food and Drug Administration’s requirements for device identification and usage instructions.

Language support for quality management system documentation and risk management files to support orthopedic product lifecycle compliance.

Certified translations for bilingual labeling, marketing materials, and licensing submissions for the Canadian medical device market.

Translation of technical documentation and regulatory filings to meet Pharmaceutical and Medical Devices Agency guidelines.

Multilingual support for product registration, labeling, and clinical evidence submission for orthopedic devices entering the Chinese market.

Brazilian Portuguese translations for labeling, IFUs, and registration dossiers to support compliance with the Brazilian Health Regulatory Agency.

All translations are completed and reviewed under robust quality systems that conform to ISO 17100 for translation services and ISO 9001:2015 for quality management. Our structured QA process includes multi-step linguistic review, terminology validation, and regulatory alignment to minimize compliance risk and ensure global readiness.

Technology-Backed Human Expertise

Technology-Backed Human Expertise

At Sesen, we combine advanced language technology with expert human translators to deliver orthopedic device translations that are fast, consistent, and regulatory-ready. Our approach is purpose-built for the life sciences sector and designed to meet the high linguistic and technical demands of global orthopedic device manufacturers.

Our proprietary SesenGPT engine supports translators with pre-validated terminology suggestions and content alignment, enabling faster turnaround and improved consistency across high-volume orthopedic documentation.

We maintain dedicated translation memory databases for each client, capturing previously approved content to ensure consistency, reduce costs, and accelerate project timelines.

Our linguists work with client-approved termbases to ensure accurate usage of anatomical, biomechanical, and surgical terms. This safeguards clinical clarity and supports compliance with regulatory labeling standards.

We offer in-context QA capabilities that allow linguists to view translations within actual label layouts, IFU panels, and packaging designs. This ensures accuracy in formatting, truncation, and line-break handling.

Our team provides multilingual DTP services to deliver fully formatted output for multi-panel IFUs, carton labels, surgical manuals, and regulatory submissions. Layouts are validated for both linguistic accuracy and visual compliance across target languages.

By combining intelligent automation with medically trained linguists and ISO-certified QA processes, Sesen delivers orthopedic translations that meet the highest standards of quality, speed, and global usability.

Dedicated Project Management for Orthopedic Clients

Dedicated Project Management for Orthopedic Clients

Successful orthopedic device translation requires more than linguistic accuracy. It demands expert coordination, regulatory awareness, and end-to-end workflow control. At Sesen, every orthopedic client is supported by a dedicated project manager with experience in orthopedic medical devices and multilingual compliance requirements.

Our project managers serve as strategic partners, overseeing every aspect of the translation process from initial scoping to final delivery. They work closely with your internal teams—including regulatory affairs, technical writing, and marketing—to ensure alignment with product launch timelines and submission milestones.

Key project management features include:

Our project managers understand the clinical and technical language specific to orthopedic devices, from implant nomenclature to surgical instrumentation. This enables more accurate planning, terminology validation, and QA oversight.

We implement weekly project status updates, QA checkpoints, and tracked revision cycles to provide full visibility and control over project progress. Each deliverable undergoes rigorous linguistic and regulatory review.

Sesen manages a network of native medical linguists and desktop publishing experts across all major markets. Our project managers synchronize translation workflows for simultaneous multi-language releases, ensuring consistent quality and regulatory compliance across regions.

This structured and responsive approach ensures that your orthopedic documentation is translated accurately, reviewed thoroughly, and delivered on schedule—supporting faster approvals, smoother audits, and global market success.

Why Choose Sesen

Why Choose Sesen

Sesen is a trusted partner for orthopedic device manufacturers seeking precise, compliant, and globally scalable translation solutions. We bring deep industry specialization, proven linguistic accuracy, and enterprise-grade workflows to every project.

We work solely within the life sciences sector, bringing deep regulatory knowledge to every translation project—from pharmaceuticals and biologics to medical devices and public health programs.

Our global network of professional native linguists includes subject-matter experts in clinical research, regulatory affairs, and medical writing, ensuring accurate and submission-ready translations across document types.

Sesen delivers multilingual submission support in over 150 languages, with full alignment to local authority terminology, formatting standards, and regional regulatory expectations.

Our ISO-certified processes, secure infrastructure, and scalable translation platform enable rapid turnaround and consistent quality, even for large or multi-country submissions.

Every project is managed by a dedicated team that understands global submission cycles, eCTD requirements, and the importance of meeting critical filing deadlines with precision and clarity.

With Sesen, you gain a language partner that understands the precision, quality, and speed required in the orthopedic device industry.

Related Services

Sesen offers a comprehensive portfolio of life sciences translation services that support orthopedic device manufacturers across every stage of the product lifecycle. Explore our related services to strengthen global compliance and streamline international market access:

  • End-to-end translation support for Class I, II, and III medical devices, including labeling, technical documentation, and regulatory submissions across over 150 languages.
  • Surgical Device Translation Services
    Specialized translation for surgical instruments and procedure-specific content, including user manuals, technique guides, and multilingual training materials.
  • Professional translation services aligned with the European Union Medical Device Regulation, supporting CE marking compliance for orthopedic implants and surgical systems.
  • Detailed linguistic review of labeling and packaging content directly within final layouts, ensuring terminology accuracy, visual consistency, and region-specific compliance.
  • Certified translations of IFUs for implantable and reusable orthopedic devices, formatted for multi-panel folding, electronic delivery, or localized print production.
  • High-precision translation of CERs and supporting clinical data to meet EU MDR and other global regulatory requirements, ensuring clarity and consistency in multilingual submissions.

Sesen offers a comprehensive portfolio of life sciences translation services that support orthopedic device manufacturers across every stage of the product lifecycle. Explore our related services to strengthen global compliance and streamline international market access:

Frequently Asked Questions About Orthopedic Device Translation

Sesen provides professional orthopedic device translation services in over 150 languages, including all major EU, Asian, and Latin American languages. We tailor translations to meet regional regulatory and linguistic standards for each target market.

Yes. Our multilingual desktop publishing (DTP) team formats translated IFUs, labels, surgical manuals, and cartons to match the original layout. We support multi-panel folding, print-ready files, and in-context layout verification for compliance and clarity.

All translations are performed by certified medical linguists and reviewed under ISO 17100 and ISO 9001:2015 quality management systems. We align terminology with regional regulatory frameworks such as EU MDR, FDA 21 CFR, and PMDA guidelines to ensure accuracy and audit readiness.

Yes. Sesen is equipped to manage fast-track orthopedic translation projects with simultaneous multi-language workflows. Our dedicated project managers coordinate linguists, reviewers, and DTP specialists to meet compressed launch and submission schedules.

Absolutely. Our translators are native-speaking medical professionals with specialized expertise in orthopedic terminology, device mechanics, and surgical workflows. They understand the clinical and technical nuances required for high-stakes orthopedic content.

Let’s Talk About Your Orthopedic Device Translation Needs

Whether you are launching a new joint replacement system, updating IFUs for global compliance, or localizing surgical robotics documentation, Sesen is here to help. Our expert linguists and ISO-certified workflows ensure your orthopedic content is accurate, compliant, and ready for global markets.

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