Sign In

What Is Medtech Translation?

Medtech translation refers to the specialized adaptation of medical technology content into multiple languages to support safe device use, regulatory approval, and international market access. Unlike general translation, it requires deep knowledge of technical terminology, clinical concepts, and compliance frameworks that govern the medical technology sector.

The global medtech industry is projected to exceed 700 billion USD by 2030, with growth driven by innovation in diagnostics, connected devices, and digital health solutions. For companies seeking to expand into new markets, multilingual documentation is a prerequisite for success. Regulatory bodies worldwide mandate accurate translation of labeling, instructions for use, and technical documentation as part of device submissions and post-market surveillance. Inaccurate or incomplete translations can result in delayed approvals, product recalls, or patient safety risks.

Sesen specializes exclusively in life sciences translation, making us uniquely qualified to support medical technology companies with multilingual documentation needs. Our network of professional native linguists covers 150 languages and is backed by ISO-certified processes, including ISO 17100 for translation services and ISO 13485 for medical device quality management. This ensures that every project meets the rigorous standards required by the FDA, EU MDR, IVDR, and other international regulators.

By combining industry-specific expertise with advanced terminology management and technology-enabled workflows, Sesen delivers medtech translation services that accelerate market entry, maintain compliance, and protect patient safety.

Read More Read Less

Why Accurate Translation Is Critical in Medtech

Accurate translation is fundamental to the safe and effective use of medical technology. Even minor errors in device labeling or instructions for use can lead to patient injury, misuse of the product, or adverse clinical outcomes. For manufacturers, the consequences extend beyond safety risks to potential recalls, penalties, and loss of trust among healthcare providers and patients.

Regulatory compliance adds another layer of complexity. Authorities such as the FDA, the European Medicines Agency, and notified bodies under the EU MDR and IVDR require that device documentation, labeling, and packaging be translated into the official languages of each target market. ISO 13485 further emphasizes the role of multilingual quality documentation as part of a compliant quality management system. Without precise translations, companies face delayed approvals, rejected submissions, or regulatory nonconformance.

Market expansion also depends on clear communication. Poorly translated user manuals, training materials, or software interfaces can increase product support costs and undermine adoption in new regions. Inaccurate translations expose companies to litigation risk, particularly in highly regulated jurisdictions where lawsuits can stem from misinterpreted instructions. Equally damaging are reputational risks, as mistranslations can erode brand credibility and compromise long-term market share.

For medtech companies operating in a global environment, accurate translation is not only a compliance requirement but a strategic advantage. It reduces financial risk, accelerates international launches, and reinforces a company’s reputation for quality and safety.

Medtech Documents and Content We Translate

Sesen supports the full spectrum of medical technology documentation required for regulatory compliance, clinical use, and global commercialization. Each content type demands specialized linguistic expertise and strict quality controls to ensure accuracy, consistency, and usability.

Clear, multilingual labeling is essential for patient safety and regulatory approval. We translate instructions for use (IFUs), user manuals, carton labels, and unique device identification (UDI) data in line with FDA, EU MDR, and IVDR requirements.

Our team handles technical files and submissions for global authorities, including EU MDR documentation, FDA 510(k) applications, and CE marking dossiers. Accurate translation helps streamline the approval process and avoids costly delays.

We provide multilingual support for clinical evaluation reports (CERs), post-market surveillance data, vigilance reporting, and complaint handling records. These translations ensure compliance with evolving regulatory frameworks and support ongoing device safety.

From product brochures and commercial websites to multilingual eLearning modules and product demonstration guides, our translations help medtech companies communicate effectively with healthcare professionals and end users across global markets.

Sesen translates device software interfaces, mobile apps, and monitoring dashboards with in-context tools that preserve usability and compliance. This includes adapting digital health platforms and companion applications to meet local market expectations.

We translate quality management content such as standard operating procedures (SOPs), risk assessments, corrective and preventive action (CAPA) reports, and audit documentation. These materials are critical for ISO 13485 certification and regulatory audits.

Our services extend to production-related materials, including assembly guides, device specifications, and manufacturing SOPs. Precise technical translations reduce errors on the production line and support global supply chain efficiency.

By covering this breadth of documentation, Sesen provides medtech companies with a single trusted partner for multilingual content across the entire device lifecycle.

Sesen’s Expertise in Medtech Translation

Sesen’s Expertise in Medtech Translation

Sesen delivers translation services designed specifically for the medical technology sector. Unlike general language service providers, we work exclusively within life sciences, giving our clients the assurance that every project is managed with regulatory awareness, subject matter expertise, and industry-specific precision.

Our sole focus on life sciences ensures that every translation is grounded in sector knowledge, from complex device documentation to regulatory submissions. This specialization reduces risk and supports faster regulatory approval.

We work with professional native translators who bring both linguistic proficiency and medtech subject matter expertise. Each linguist is carefully vetted to handle highly technical content such as IFUs, software interfaces, and quality documentation.

Sesen operates under rigorous international standards, including ISO 17100 for translation services, ISO 13485 for medical device quality management, and ISO 9001:2015 for overall quality systems. These certifications demonstrate our commitment to accuracy, consistency, and compliance.

We combine the precision of human expertise with the efficiency of technology. Our workflows leverage translation memory, terminology management, and machine translation post-editing (MTPE) when appropriate, ensuring consistency across large documentation sets and reducing turnaround times.

Our DTP specialists adapt diagrams, schematics, and packaging layouts across multiple languages. This ensures that translated content integrates seamlessly into regulated materials without formatting errors or usability issues.

For device labeling, Sesen provides in-context linguistic review and label quality assurance to verify that translations fit correctly, display accurately, and align with regional regulatory requirements. This step helps avoid costly errors in labeling and packaging.

By combining deep life sciences expertise with ISO-certified processes and advanced translation technology, Sesen delivers medtech translation services that support compliance, improve efficiency, and protect patient safety across global markets.

Software Localization for Medtech

Medical devices increasingly rely on software interfaces, mobile applications, and connected platforms to support clinical workflows and patient engagement. Accurate software localization is essential to ensure usability, regulatory compliance, and user safety across global markets.

Sesen provides medtech software localization services that adapt device interfaces, dashboards, and mobile applications into multiple languages while preserving functionality and clarity. Our in-context string translation system allows linguists to view and translate text directly within the live interface, reducing testing cycles and minimizing the risk of display errors or truncated text.

We support localization for companion apps, patient monitoring tools, and digital health platforms, enabling seamless interaction for healthcare professionals and patients worldwide. By addressing both linguistic accuracy and technical integration, we help medtech companies deliver software that meets local expectations and performs consistently across devices and regions.

Compliance with IEC 62366 (usability engineering) and ISO 9241 (human-computer interaction) is central to our approach. Our localization workflows align with these standards to ensure that multilingual interfaces remain intuitive, accessible, and compliant with global usability requirements.

With Sesen, medtech companies gain a trusted partner for device interface translation, digital health localization, and global software deployment, supporting both regulatory success and user adoption.

Read More Read Less

Regulatory Alignment Across Markets

Medtech companies must meet strict regulatory requirements before devices can be approved and marketed internationally. Each region enforces its own language and documentation standards, making accurate translation a critical step in the compliance process.

The U.S. Food and Drug Administration requires that labeling, packaging, and instructions for use (IFUs) clearly communicate safety and performance information. Accurate translation of these materials is essential for 510(k) submissions, device registration, and post-market documentation.

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) mandate multilingual documentation as part of CE marking. Technical files, labeling, IFUs, and clinical evaluation reports must be available in the official languages of each member state to achieve and maintain market authorization.

Across Asia-Pacific and the Americas, regulators also require precise, compliant translations. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), China’s National Medical Products Administration (NMPA), Health Canada, and Brazil’s ANVISA all enforce language requirements that cover labeling, submissions, and quality system documentation.

Sesen has extensive experience supporting global medtech companies in meeting these diverse regulatory frameworks. Our translations are delivered through ISO 13485–compliant processes, ensuring accuracy, traceability, and audit readiness across markets.

Trusted by medtech companies for FDA 510(k), EU MDR, IVDR, Health Canada, NMPA, and PMDA submissions.

Quality Assurance and Risk Management

Quality Assurance and Risk Management

In the medtech sector, quality is inseparable from compliance and patient safety. Sesen applies a rigorous, ISO-certified quality management framework to every translation project to reduce risk and guarantee accuracy.

Each project follows a structured workflow that includes initial translation, independent linguistic review, and final validation. This process ensures linguistic precision, technical accuracy, and regulatory alignment across all deliverables.

We maintain controlled terminology using client glossaries, term bases, and style guides. Our terminology management tools improve consistency across large documentation sets and support adherence to regulatory standards such as ISO 13485 and EU MDR.

Specialized review processes are applied to device labels, IFUs, and packaging. In-context QA allows linguists to check translations within the final layout, ensuring accuracy in placement, formatting, and compliance with regional labeling requirements.

By combining controlled terminology with validated translation and review workflows, Sesen minimizes the risk of errors that could lead to regulatory findings, market delays, or patient safety issues. Our quality system is designed to provide audit-ready documentation and peace of mind for medtech manufacturers.

With Sesen, quality assurance is not an afterthought but an integral part of delivering accurate, compliant, and reliable medtech translation services.

Case Studies and Proof of Experience

Case Studies and Proof of Experience

Sesen has partnered with leading medical technology companies to deliver accurate, compliant, and scalable translation solutions. Our work spans device labeling, IFU adaptation, regulatory submissions, and multilingual software localization, demonstrating our ability to support clients across the entire product lifecycle.

Sesen translated and adapted labeling and packaging for a global in-vitro diagnostics manufacturer. The project covered multiple languages required for EU MDR compliance and included in-context label QA to ensure accuracy, consistency, and regulatory approval readiness.

A multinational medical device company engaged Sesen to translate instructions for use and user manuals into 25 languages for distribution across Europe, Asia, and Latin America. Our ISO-certified workflows and multilingual desktop publishing ensured that complex technical content was both accurate and formatted for regulatory compliance.

These projects highlight Sesen’s ability to meet the demands of top medtech organizations. By combining subject matter expertise, technology-enabled workflows, and ISO-certified quality systems, we deliver results that accelerate market access and safeguard patient safety.

Why Choose Sesen

Why Medtech Companies Choose Sesen

Medtech manufacturers operate in one of the most highly regulated industries, where translation accuracy directly affects compliance, safety, and global market success. Sesen is trusted by medical technology companies worldwide because we combine specialized expertise with scalable resources and ISO-certified processes.

Our workflows are built around ISO 17100 for translation services, ISO 13485 for medical device quality management, and ISO 9001:2015 for quality systems. We translate with regulatory requirements in mind, supporting submissions to the FDA, EU MDR, IVDR, and other global authorities.

Sesen’s professional native translators are subject matter experts in medtech. They understand the technical terminology, clinical context, and regulatory implications of each project, ensuring precise and consistent translations across device labeling, IFUs, and technical documentation.

With coverage in 150 languages and access to a large global linguist network, we support projects ranging from single-market submissions to worldwide device launches. Our scalable approach allows clients to expand confidently into multiple regions.

Agile workflows, advanced terminology management, and translation memory technology help us deliver faster turnaround times without compromising quality. This enables medtech companies to accelerate time-to-market and stay competitive in fast-moving global markets.

Each client benefits from a dedicated project manager who provides weekly status reports, proactive communication, and flexible engagement models. This collaborative approach ensures transparency, responsiveness, and alignment with client priorities.

By combining compliance expertise, linguistic precision, global reach, efficiency, and collaborative support, Sesen delivers medtech translation services that reduce risk, streamline approvals, and strengthen international market success.

Related Services

  • Specialized translation for device manuals, IFUs, packaging, and technical documentation with ISO 13485 alignment and global regulatory expertise.
  • Accurate translation of instructions for use, user manuals, and device documentation to meet FDA, EU MDR, and IVDR requirements.
  • Multilingual translation and desktop publishing for drug and device packaging, carton labels, and patient-facing inserts in compliance with global regulations.
  • Specialized support for informed consent forms, patient materials, regulatory submissions, and clinical study documentation in over 150 languages.
  • End-to-end localization of device interfaces, dashboards, and digital health platforms with in-context review to ensure usability and compliance.
  • Specialized quality assurance services to validate translated labels and packaging in their final layouts, reducing compliance risk and ensuring accuracy.

Frequently Asked Questions

Medtech translation services cover the adaptation of medical technology documentation, labeling, IFUs, software interfaces, and regulatory submissions into multiple languages. These services require subject matter expertise, adherence to ISO standards, and knowledge of regional regulations to ensure compliance and patient safety.

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require that technical documentation, labeling, and IFUs be available in the official languages of all EU member states where a device is marketed. Accurate translations are essential to achieve CE marking and maintain access to the European market.

The most common requirements include English, German, French, Spanish, Italian, and Dutch for the EU, along with Japanese, Chinese, and Korean for Asia. Other priority markets often include Portuguese for Brazil, Arabic for the Middle East, and Russian for Eastern Europe. The exact languages depend on the target countries for device distribution.

Sesen applies ISO 17100 and ISO 13485 certified processes that include professional native translators with medtech expertise, terminology management tools, and a multistep QA workflow. In-context label and layout review ensures that translated IFUs meet both regulatory and usability requirements.

Yes. Sesen localizes device interfaces, mobile applications, and connected health platforms using in-context translation tools that preserve functionality and compliance. Our workflows align with IEC 62366 and ISO 9241 usability standards to ensure multilingual interfaces remain clear, accurate, and user-friendly.

Take the Next Step with Sesen

Global medtech leaders trust Sesen to deliver accurate, compliant, and scalable translation services that support regulatory approval, accelerate time-to-market, and safeguard patient safety. Whether you need multilingual labeling, IFU translation, or software localization, our team of life sciences experts is ready to support your global expansion.

Partner with Sesen for translation services that combine regulatory expertise, linguistic accuracy, and global reach.

REQUEST A QUOTE REQUEST A QUOTE

– Receive a tailored estimate based on your project requirements.

SCHEDULE A DEMO SCHEDULE A DEMO

– See how our ISO-certified workflows and technology-enabled translation solutions can support your medtech documentation.

DOWNLOAD CAPABILITIES PDF DOWNLOAD CAPABILITIES PDF

– Learn more about Sesen’s full range of medtech translation services in a shareable format.