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Accurate Labeling Translations for Global Medical Device Compliance
Effective medical device labeling is essential for regulatory approval, safe device operation, and global market access. Unlike pharmaceutical labeling, which focuses on dosage and pharmacokinetics, medical device labeling must convey clear, device-specific instructions for use, safety warnings, and technical specifications—accurately translated across multiple languages and formats.
At Sesen, we specialize in medical device labeling translation with regulatory, linguistic, and usability precision—ensuring your content complies with global health authority requirements, including the FDA, EU MDR, UK MHRA, Health Canada, and PMDA.
Our team of professional native linguists, supported by ISO 13485-certified quality systems, delivers translations that are not only technically accurate but also user-focused and compliant with evolving regional regulations.
Explore how Sesen’s specialized workflows and subject matter expertise set us apart from general or drug-focused translation providers.
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Why Medical Device Labeling Translation Matters
Accurate and compliant labeling translations are critical to the safe and effective use of medical devices in global markets. Poorly translated instructions or safety warnings can lead to clinical errors, regulatory non-compliance, and increased product liability risks.
At Sesen, we understand the high stakes of medical device labeling and deliver language solutions that support:
Patient Safety and Clinical Accuracy
Precise translations of Instructions for Use (IFUs), user manuals, and safety labeling ensure healthcare professionals and patients can operate devices correctly—minimizing the risk of misuse, adverse events, and product recalls.
Compliance with Global Regulatory Bodies
Our labeling translations align with the stringent requirements of the FDA, EU MDR/IVDR, UK MHRA, Health Canada, PMDA (Japan), NMPA (China), and other regulatory agencies. We support region-specific formatting, terminology, and labeling standards for full compliance across jurisdictions.
Multilingual Usability and Risk Mitigation
We deliver linguistically and culturally appropriate translations that promote readability and comprehension, helping to reduce risks associated with misinterpretation or improper device use in diverse markets.
Faster Global Market Access
High-quality labeling translations enable medical device companies to accelerate regulatory submissions, product launches, and global distribution strategies—without delays caused by language or compliance issues.
With Sesen, you gain a strategic partner that understands the complex intersection of language, regulation, and device usability.
Types of Medical Device Labeling We Translate
Sesen provides end-to-end translation services for all components of medical device labeling, supporting compliance, usability, and regulatory approval in over 150 languages. We specialize in translating labeling content across both print and digital formats, ensuring consistency, accuracy, and readability for global users.
Instructions for Use (IFU)
Critical for regulatory submissions and safe usage, IFUs require clear, accurate translations to guide healthcare professionals and patients through device operation, maintenance, and troubleshooting.
User Manuals and Operating Instructions
We translate complex device manuals into target languages while preserving technical detail, ensuring users across all markets understand how to install, configure, and operate the device correctly.
Packaging Labels and Outer Cartons
Sesen ensures product labeling—including model numbers, serial identifiers, expiration dates, and storage instructions—is localized to meet regional formatting standards and comply with language requirements on primary and secondary packaging.
Software and On-Device Display Text
For software-driven medical technologies, we translate user interface elements, control panel text, and embedded system messages to ensure localization accuracy across devices.
Unique Device Identifier (UDI) Labels
We support multilingual UDI labeling to meet regional compliance obligations, including structured data elements and device identifiers required by the FDA, EU, and other regulatory systems.
eIFU and Digital Labeling Content
As more manufacturers transition to electronic instructions for use (eIFU), Sesen provides localization of web-based and digital labeling content, including PDFs, HTML files, and XML-structured content.
Safety Symbols, Warnings, and Precautions
Translating safety-critical content requires linguistic precision and adherence to international standards (e.g., ISO 15223). Our team ensures that hazard statements, contraindications, and precautionary language are accurate, standardized, and culturally appropriate.
Sesen’s medical device labeling translations are engineered for accuracy, usability, and full compliance—reducing time-to-market and supporting global product success.
Regulatory Compliance & Quality Assurance
Sesen’s medical device labeling translation services are designed to meet the highest standards of regulatory compliance and linguistic accuracy—ensuring your content is inspection-ready and aligned with global health authority expectations.
Full Compliance with Global Regulations
We translate labeling content in strict accordance with international and regional regulatory frameworks, including EU MDR/IVDR, FDA 21 CFR Part 801, ISO 13485:2016, Health Canada, UK MHRA, and PMDA. Our processes are tailored to the classification and risk level of your device, from Class I through Class III.
Validated Glossaries and Style Guides
Sesen maintains client-specific glossaries and style guides to ensure consistent use of approved medical terminology across all labeling components. We align translations with international nomenclature systems and industry-specific language.
Multistep Quality Assurance Workflow
Each project undergoes a rigorous multistep QA process, including initial translation by professional native linguists, followed by independent review, in-country validation, and linguistic QA checks. This layered approach ensures regulatory-grade precision and contextual accuracy.
Translation Memory & Version Control
We leverage advanced translation memory (TM) tools to maintain consistency across product lines, accelerate turnaround for updates, and reduce costs. Our version control protocols track changes to support compliance audits and document traceability.
Risk-Based Validation by Device Classification
Translation workflows are adapted based on the device’s regulatory class. High-risk (Class III) devices receive enhanced validation and linguistic review steps to meet the scrutiny of notified bodies and competent authorities.
With Sesen, your labeling translations are not only linguistically correct—they’re technically compliant, audit-ready, and aligned with evolving global regulatory demands.
Expert Linguistic and Subject Matter Teams
At Sesen, medical device labeling translation is led by a team of highly trained professionals who combine linguistic fluency with deep domain expertise. Our cross-functional approach ensures every project meets the complex technical, regulatory, and usability standards required for global device deployment.
Professional Native Linguists with Medical Device Specialization
We work exclusively with professional native linguists who possess in-depth knowledge of medical device terminology, regulatory context, and end-user requirements. Every linguist undergoes a rigorous vetting process and continuous training on device-specific content.
Engineering and Regulatory Expertise
Our in-house and partner teams include regulatory specialists and localization engineers who understand the technical architecture of medical devices, including software components, labeling systems, and country-specific compliance formats.
Integrated Language and Technical Review
Sesen’s cross-functional teams pair expert linguists with engineers, quality reviewers, and regulatory consultants to deliver linguistically accurate and technically validated translations. This integrated model reduces rework and ensures content is correct at both the language and system levels.
Usability-Driven Translation Support
We go beyond translation accuracy to support usability-tested layouts and readability requirements, particularly under EU MDR Annex I and FDA human factors guidance. Our teams are equipped to optimize content for end-user clarity and regional accessibility standards.
By combining linguistic precision with subject matter expertise, Sesen delivers labeling translations that are both regulatory-compliant and optimized for safe, effective device use across global markets.
Technology-Driven Translation Workflows for Medical Device Labeling
Sesen combines the precision of human expertise with advanced translation technologies to deliver accurate, scalable, and compliant medical device labeling translations. Our technology-enabled workflows ensure faster turnaround, reduced costs, and enhanced consistency across labeling assets—without compromising regulatory integrity.
CAT Tools and Translation Memory for Speed and Consistency
We leverage industry-leading computer-assisted translation (CAT) tools and translation memory (TM) systems to maintain consistent terminology across product families and documentation updates. These tools also accelerate delivery timelines and optimize reuse of validated content across IFUs, labels, and manuals.
MTPE Workflows for Scalable Updates
For clients seeking to streamline large-scale or repetitive labeling updates, Sesen offers machine translation post-editing (MTPE)—only when explicitly approved. This hybrid workflow combines custom-trained MT output with human linguistic review to ensure regulatory-grade quality while reducing cost and turnaround time.
Secure, AWS-Based Translation Management System (TMS)
All projects are managed through Sesen’s secure AWS-hosted TMS, which features audit trails, role-based access control, and full data encryption. This cloud infrastructure supports compliance with data protection regulations, including GDPR and HIPAA, while providing real-time project visibility.
Seamless Integration with Labeling and CMS Platforms
We support direct integration with client-side labeling systems, structured content platforms, and content management systems (CMS). Our engineers can enable automated handoffs, XML-based workflows, and version control to streamline multilingual content delivery within your labeling ecosystem.
Sesen’s technology-enabled human translation model ensures every labeling project benefits from operational efficiency, linguistic precision, and enterprise-grade security—ready for regulatory inspection and global distribution.
Multilingual DTP & Layout Compliance
Sesen provides end-to-end multilingual desktop publishing (DTP) services to ensure translated medical device labeling meets both linguistic and regulatory layout requirements across global markets. Our production teams work in tandem with linguists and engineers to deliver print- and digital-ready files that comply with region-specific readability, formatting, and usability standards.
Support for All Major Languages and Scripts
We handle a full range of languages and writing systems, including bidirectional scripts (Arabic, Hebrew), CJK (Chinese, Japanese, Korean), Cyrillic, and extended Latin alphabets. Our DTP specialists ensure accurate character rendering, line breaks, and typographic conventions for every target market.
Layout Adaptation for Regulatory Readability
Sesen adapts translated content to meet formatting requirements set forth by the EU MDR, FDA, and other regulatory bodies, including minimum font sizes, spacing, and layout structure for enhanced readability and usability. We ensure content remains clear and accessible for both healthcare professionals and patients.
Formatting Validation in Structured Content
Our teams work within structured content environments such as XML, InDesign, FrameMaker, and DITA, ensuring layout integrity is preserved throughout translation. We validate formatting across different output formats (PDF, print, digital) and manage version control for consistent labeling across product lines.
Sesen’s multilingual DTP services ensure your labeling translations are not only linguistically accurate but also regulatory-compliant, visually consistent, and production-ready—no matter the language or document format.
Global Language Coverage for Regulatory-Ready Labeling
Sesen supports multilingual medical device labeling across global markets, helping life sciences companies meet local language requirements and expand international reach with confidence. We provide high-quality translations in over 150 languages, ensuring linguistic accuracy, cultural appropriateness, and compliance with regional regulatory guidelines.
150+ Languages for Global Device Labeling
From EU languages such as French, German, Italian, and Spanish to Asian, Middle Eastern, and Latin American languages, Sesen covers the full range of languages required for regulatory submissions and commercial distribution. Whether you need labeling in Japanese for PMDA compliance or Arabic for Gulf market registration, our teams are equipped to support your product launch across multiple regions.
Coverage Across Key Regulatory Markets
We specialize in supporting clients across Europe, North America, Latin America (LATAM), Asia-Pacific (APAC), and the Middle East and North Africa (MENA). Our expertise includes navigating language and formatting standards for health authorities such as the European Commission (MDR/IVDR), FDA, Health Canada, PMDA, NMPA, and SFDA.
In-Country Linguistic Validation
For added confidence and local compliance, Sesen offers in-country review and linguistic validation services upon request. This includes review by native-speaking subject matter experts within the target market to verify accuracy, regulatory alignment, and cultural appropriateness—particularly for high-risk Class II and III devices.
Sesen’s global language capabilities ensure your medical device labeling is clear, compliant, and ready for market entry—no matter the region or regulatory pathway.
Use Cases & Project Types
Sesen supports a wide range of medical device labeling translation projects—from high-volume global rollouts to urgent regulatory updates—helping manufacturers maintain compliance, accelerate time-to-market, and scale efficiently across languages and markets.
New Product Launches with Full Labeling Sets
We provide end-to-end translation and localization support for new product introductions, including IFUs, user manuals, packaging labels, UDI elements, and regulatory inserts. Our multilingual workflows ensure consistency and compliance across all labeling components and regions at launch.
Labeling Updates for Design, Regulatory, or Safety Changes
Sesen manages translation updates tied to regulatory amendments (e.g., EU MDR/IVDR), product redesigns, field safety notices (FSNs), or corrective actions. Our translation memory and version control systems ensure rapid turnaround while maintaining linguistic consistency with previous versions.
Country-Specific Language Expansion for Existing SKUs
When expanding market presence, we support language additions to existing labeling sets to meet local requirements. Our teams adapt translated content to regional regulations, formats, and linguistic nuances without disrupting existing document architecture.
eIFU Migration and Digital Labeling Projects
As the industry shifts toward digital content delivery, Sesen supports eIFU (electronic Instructions for Use) migrations, converting and localizing structured XML, PDF, or HTML content for online access. We ensure language accuracy, regulatory alignment, and user-friendly formatting across digital platforms.
With deep domain expertise and ISO 13485-certified processes, Sesen delivers labeling translation solutions for every stage of the product lifecycle—backed by global scalability and regulatory precision.
Why Sesen
Sesen is a trusted partner to leading life sciences companies for medical device labeling translation, combining regulatory expertise with linguistic precision to support compliant, high-quality multilingual labeling at scale. Our services are built on certified processes, experienced teams, and a commitment to responsive delivery.
ISO 13485:2016 and ISO 17100 Certified Workflows
Our translation processes are fully certified to ISO 13485:2016 (medical devices) and ISO 17100 (translation services), ensuring risk-managed, quality-assured workflows aligned with global regulatory requirements. From terminology management to change control, our systems are engineered for audit readiness and traceability.
Dedicated Project Managers with Medical Device Expertise
Every client is supported by a dedicated project manager with deep experience in medical device documentation, regulatory labeling standards, and multilingual content delivery. Our project managers act as strategic partners—proactively identifying compliance risks, managing timelines, and coordinating complex multilingual workflows.
Proven Experience with Class II and III Devices
Sesen has successfully delivered multilingual labeling for a wide range of Class II and Class III medical devices, including implantable, diagnostic, and software-driven products. Our teams are familiar with the heightened regulatory scrutiny these devices require and tailor workflows accordingly.
Agile Turnaround and Rush Support
We offer flexible turnaround options, including expedited and weekend workflows, to meet tight regulatory deadlines and product launch timelines. Our scalable infrastructure and global linguist network enable rapid delivery without compromising quality.
With Sesen, life sciences companies gain a translation partner that understands the complexities of regulated medical device labeling—and delivers the quality, speed, and compliance needed to succeed in global markets.
