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Why Implantable Device Translation Matters

Why Implantable Device Translation Matters

Implantable medical devices are classified as Class II and Class III by global regulatory authorities, including the FDA in the United States and the European Commission under the EU Medical Device Regulation (MDR). These classifications reflect the higher risk profile of implants such as pacemakers, stents, neurostimulators, and cochlear implants, where even minor translation errors can have serious consequences.

Accurate multilingual communication is critical for manufacturers entering global markets. Regulatory submissions, Instructions for Use (IFUs), and patient instructions must be translated with precision to meet language compliance requirements in every target country. Inaccurate or incomplete translations can result in delayed approvals, product recalls, or safety risks for patients.

Professional implantable device translation ensures that clinical terminology, surgical protocols, and labeling are consistent across all languages. By partnering with a specialized provider, manufacturers reduce regulatory risk, support patient safety, and achieve faster market access worldwide.

Types of Implantable Devices We Translate

Types of Implantable Devices We Translate

Sesen provides specialized implantable device translation services across a wide range of high-risk medical technologies. Our domain-specific linguists collaborate with manufacturers, clinical teams, and regulatory authorities to deliver precise and compliant translations tailored to each implant type.

Translation of documentation for pacemakers, coronary and peripheral stents, defibrillators, and related accessories. Content includes Instructions for Use (IFUs), surgical implantation guides, patient instructions, and regulatory submissions to support both pre-market approvals and post-market surveillance.

Multilingual translation for hip and knee replacements, spinal fixation devices, trauma plates, and bone screws. Materials include device manuals, surgical protocols, product labeling, and clinical documentation to ensure accuracy and compliance across international markets.

Translation of neurostimulators, deep brain stimulators, and related neurological devices. Services cover IFUs, surgical planning documents, patient consent forms, and regulatory filings, with a focus on precision terminology required for Class III high-risk devices.

Specialized translation for cochlear implants, retinal implants, and sensory restoration systems. Content includes labeling, clinical trial documentation, patient education materials, and technical specifications designed to meet the needs of both regulators and end-users.

Language support for implantable infusion pumps, contraceptive implants, and sustained-release delivery systems. Translated materials include product packaging, prescribing information, IFUs, and compliance documentation for FDA, EMA, and EU MDR submissions.

Translation of prosthetic screws, abutments, and maxillofacial implants. Content includes surgical instructions, patient-facing documentation, product catalogs, and regulatory dossiers to support safe use and global market entry.

Implantable Device Documents We Translate

Sesen delivers accurate, compliant, and ISO-certified translations for all documentation required to bring implantable medical devices to global markets. From regulatory submissions to patient-facing materials, our services ensure clarity, compliance, and consistency across 150 languages.

Translation of IFUs for implantable devices, including patient instructions, surgical protocols, and physician guidelines. We adapt medical terminology for both professional and lay audiences while preserving clinical accuracy to meet regulatory and safety requirements.

Multilingual support for FDA 510(k) applications, Premarket Approval (PMA) dossiers, and EU MDR technical documentation. Our translations follow regulatory authority guidelines to help manufacturers secure timely approvals and maintain compliance in multiple jurisdictions.

Translation of trial protocols, investigator brochures, informed consent forms, and case report forms for implantable device studies. We ensure precision in medical terminology and alignment with ICH-GCP standards to support accurate data collection and cross-border trial operations.

Translation of implant labels, package inserts, and device packaging across multiple languages. Our linguists and DTP specialists ensure correct formatting, readability, and compliance with MDR, FDA UDI, and regional labeling requirements.

Translation of brochures, multilingual websites, training modules, and patient education videos for implantable devices. We adapt complex medical content into accessible language to build patient trust and strengthen global brand communication.

ISO-Certified Implantable Device Translation for Regulatory Compliance

Accurate translation is essential for implantable devices, where even small linguistic errors can lead to adverse events, regulatory delays, or product recalls. As Class II and Class III implants carry the highest safety risks, every document must meet the strictest compliance and quality standards.

Sesen delivers ISO-certified implantable device translation services backed by industry-recognized quality systems. Our operations are certified under ISO 13485 for medical device quality management, ISO 17100 for translation services, and ISO 9001:2015 for overall quality assurance. These standards guide every stage of our translation process, from terminology management to final review.

We align with the requirements of global regulatory authorities, including the U.S. FDA, the European Medicines Agency (EMA), and the EU MDR, ensuring that all translated materials are accepted for submission and market approval.

Our quality assurance workflows include multi-step linguistic review, in-context quality checks, and regulatory style guide adherence. By combining subject matter expertise with rigorous validation, Sesen helps manufacturers minimize risk, safeguard patient safety, and achieve compliance in every target market.

Our Implantable Device Translation Process

Our Implantable Device Translation Process

Sesen follows a proven implantable device translation process designed to deliver accuracy, regulatory compliance, and patient safety across all languages. Our workflows integrate specialized linguists, advanced translation technologies, and rigorous quality checks to meet the highest industry standards.

We create and maintain custom glossaries for implantable devices to ensure consistent use of medical terminology across IFUs, regulatory submissions, and patient instructions. Implant-specific glossaries reduce ambiguity and align with regulatory style guides.

Our translations are performed by professional native linguists with expertise in medical devices and implantable technologies. Each translator is trained in implant-specific terminology and regulatory documentation, ensuring both linguistic precision and subject matter accuracy.

We combine human expertise with advanced translation technologies. Computer-Assisted Translation (CAT) tools and translation memory leverage reduce costs and turnaround times while improving consistency. Machine Translation with Post-Editing (MTPE) may be applied selectively for high-volume projects, always under expert human review.

Our DTP specialists format IFUs, diagrams, and multilingual packaging so that translations are delivered in compliance with layout and labeling requirements. This includes typesetting complex diagrams, tables, and multilingual instructions for global submissions.

We conduct in-context quality assurance to verify translation accuracy within the actual document or software environment. Our label review process ensures readability, regulatory compliance, and patient safety across all languages.

By combining terminology management, expert linguists, translation technologies, and multi-step QA, Sesen provides a complete implantable device translation process that helps manufacturers achieve faster approvals, safer outcomes, and reliable multilingual communication.

Languages We Support for Implantable Devices

Sesen supports implantable device translations in over 150 languages, helping manufacturers reach global markets with accurate and compliant documentation. Our multilingual implantable device translation services cover every major region, ensuring that regulatory submissions, IFUs, and patient instructions meet local language requirements and cultural expectations.

Translations in English, French, German, Spanish, and other EU languages to support FDA, EMA, and EU MDR submissions, as well as patient-facing materials.

Chinese (Simplified and Traditional), Japanese, and Korean translations for highly regulated markets, ensuring precision for IFUs, clinical trial documents, and device labeling.

Arabic, Portuguese (Brazil), Russian, and Turkish translations to support expanding access to implantable devices in growing healthcare markets.

By providing global medical device translation expertise, Sesen enables manufacturers to accelerate international approvals, improve patient safety, and expand adoption of implantable devices worldwide.

Case Study: Implantable Device Translation Success

A leading medical device manufacturer partnered with Sesen to translate documentation for a new generation of implantable cardiac devices. The project included the translation of pacemaker Instructions for Use (IFUs) into 22 European languages to meet EU MDR requirements, as well as multilingual desktop publishing for stent packaging inserts.

Our implantable device translation process combined domain-specific linguists, custom terminology management, and ISO-certified quality assurance. The multilingual IFUs were formatted to regulatory specifications, and packaging inserts were adapted to maintain clarity and compliance across all markets.

As a result, the manufacturer achieved timely regulatory approval, reduced review cycles, and launched the devices simultaneously in multiple European countries. This case demonstrates how Sesen’s implantable device translation services directly support compliance, patient safety, and global market access.

Why Choose Sesen

Why Leading Medical Device Companies Choose Sesen

Global manufacturers of implantable devices trust Sesen as their translation partner because of our exclusive focus on life sciences and our proven ability to deliver accurate, compliant, and patient-safe translations. As one of the best implantable device translation providers, we combine subject matter expertise with advanced technology to support regulatory approval and global market success.

Provided end-to-end translation of clinical trial documentation, informed consent forms, and regulatory correspondence into 25 languages to support a global vaccine program aligned with WHO standards. Ensured consistent terminology and rapid turnaround across regions.

Delivered parallel translations of CTD Modules 1–5, labeling, and product information leaflets for simultaneous filings in the EU and Japan. Enabled the client to meet EMA and PMDA timelines through region-specific linguistic expertise and scalable workflows.

Collaborated with a national health agency to translate patient safety labeling, dosage guides, and public information materials into different European languages. Managed in-country review and formatting to meet accessibility and compliance standards for widespread public distribution.

Collaborated with a national health agency to translate patient safety labeling, dosage guides, and public information materials into different European languages. Managed in-country review and formatting to meet accessibility and compliance standards for widespread public distribution.

By combining life sciences expertise, linguistic precision, and secure technology, Sesen provides the trusted foundation medical device companies need for their implantable device translation programs.

Related Services

Sesen’s implantable device translation services are part of our broader expertise in medical device localization. By linking related areas, we help manufacturers manage multilingual requirements across all types of devices, from Class II and III implants to diagnostic and patient-facing technologies. Explore more of our specialized medical device translation solutions:

Frequently Asked Questions (FAQ)

Implantable device translation services involve the accurate and compliant translation of documentation for medical implants such as pacemakers, stents, neurostimulators, and cochlear implants. These services cover IFUs, regulatory submissions, patient instructions, labeling, and clinical trial documents required for global approvals and patient safety.

Class III implantable devices are considered high risk by regulatory authorities. Translations must be precise to avoid patient safety risks, regulatory delays, or product recalls. Accurate multilingual documentation ensures that regulators, healthcare providers, and patients receive clear and consistent information.

The most critical documents include Instructions for Use (IFUs), FDA 510(k) and PMA submissions, EU MDR technical files, patient instructions, clinical trial protocols, investigator brochures, labeling, and packaging inserts. Each requires strict adherence to regulatory and linguistic standards.

Sesen follows ISO 13485, ISO 17100, and ISO 9001:2015 certified processes to maintain regulatory and linguistic compliance. Our workflows include terminology management, multi-step review, in-context QA, and regulatory style guide adherence to align with FDA, EMA, and EU MDR requirements.

Delivery timelines depend on word count, target languages, and formatting requirements. With translation memory leverage, subject matter expert linguists, and in-house multilingual DTP, Sesen can deliver multilingual IFUs and regulatory submissions rapidly while maintaining quality and compliance.

Ready to Translate Your Implantable Device Documentation with Confidence?

Sesen provides ISO-certified implantable device translation services trusted by leading medical device manufacturers worldwide. From IFUs and regulatory submissions to patient instructions, we deliver compliant, accurate, and multilingual solutions to support your global market success.

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