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Project Overview

A global medical device manufacturer specializing in in-vitro diagnostic (IVD) systems for viral infection detection partnered with Sesen to support a large-scale product line expansion. With a growing international footprint, the client needed to deliver accurate and compliant multilingual labeling translations across diverse regulatory environments and packaging formats.

The primary objective was to translate, validate, and format labeling content in 15 languages, ensuring clarity, medical accuracy, and regulatory compliance across all target markets. Label content included Instructions for Use (IFUs), carton labels, blister packs, and safety information requiring precise alignment with global health authority standards.

The project scope covered comprehensive multilingual label updates to meet regulatory submission requirements and enable timely market access in Europe (EU), Asia-Pacific (APAC), and Latin America (LATAM). The initiative demanded linguistic precision, rapid turnaround, and strict version control to support a coordinated global product launch across multiple business units.

Sesen’s role included managing the full localization lifecycle, from source content preparation and terminology harmonization to multilingual DTP and in-context linguistic QA, ensuring each translated label was submission-ready and market-specific on delivery.

Client Challenge

The client faced the complex task of updating and translating medical device labeling in 15 languages to meet the distinct regulatory requirements of multiple international markets, including the EU, APAC, and LATAM regions. Each target country imposed specific standards for language, layout, symbols, and compliance statements, requiring careful adaptation for local approval.

The project required simultaneous delivery of all language versions to support a coordinated global product launch. This involved close alignment with internal regulatory, packaging, and commercial teams across business units and time zones.

Label content featured dense medical terminology and varied significantly across SKUs, packaging configurations, and product types. Managing this variability while maintaining linguistic consistency and technical accuracy presented a substantial challenge.

Any errors in translation, including incorrect units of measure, device use descriptions, or safety labeling, could result in regulatory delays, increased review cycles, or barriers to market entry. The client needed a reliable language partner capable of managing large-scale labeling translation with precision, speed, and regulatory alignment across all target regions.

The Sesen Solution

To meet the project’s complexity and time sensitivity, Sesen deployed a centralized and scalable translation workflow specifically tailored for medical device labeling. The workflow integrated standardized templates, approved terminology databases, and translation memory assets to ensure consistency across languages, product lines, and regions.

Sesen applied label reuse automation to streamline repetitive content across SKUs and reduce manual translation effort. This approach minimized risk, maintained uniformity in safety language, and accelerated turnaround for updated packaging components.

Our team provided multilingual desktop publishing (DTP) to align translated content with original label layouts. This preserved the integrity of label formatting, typography, and space constraints across languages, which is critical for submission-ready files and compliant packaging.

We conducted in-context linguistic quality assurance (LQA) for each label version, validating key information fields such as dosage, usage instructions, safety warnings, regulatory symbols, and expiration details. This step ensured that all translated content was clear, medically accurate, and appropriate for in-market use.

Sesen collaborated closely with the client’s internal regulatory affairs and labeling teams to align translations with regional standards, including EU MDR, IVDR, and country-specific medical device labeling regulations. This coordination helped streamline regulatory reviews and reduce back-and-forth on language issues.

All project activities were managed through a secure, audit-ready translation management platform that provided version control, stakeholder feedback resolution, and end-to-end approval tracking. This allowed for full transparency, compliance documentation, and readiness for regulatory audits.

Languages and Regions Covered

The project included comprehensive labeling translation and formatting across 15 languages, enabling product access in key global markets. Languages supported were: English, French, German, Spanish (EU and LATAM variants), Portuguese (Brazil), Italian, Russian, Polish, Arabic, Chinese (Simplified), Japanese, Korean, Thai, Vietnamese, and Turkish.

Target regions included the European Union (EU), Asia-Pacific (APAC), and Latin America (LATAM), each with distinct regulatory, linguistic, and cultural requirements for medical device labeling.

Sesen ensured all translated labels reflected regional preferences for terminology, measurement units, date formats, and medical symbols, aligned with the expectations of local health authorities. The team also adapted content for space-constrained packaging layouts, especially in languages with text expansion or complex character sets such as Chinese, Arabic, and German.

By localizing not only the language but also the formatting and regulatory context, Sesen helped the client achieve labeling compliance while improving usability and clarity for healthcare professionals and end users in each region.

Validated Results Across Markets

Sesen successfully delivered compliant, linguistically validated labels in 15 languages, fully aligned with the client’s global product rollout schedule. All language versions were completed on time, enabling synchronized launch activities across regulatory, commercial, and manufacturing teams in the EU, APAC, and LATAM regions.

The high-quality translations supported seamless regulatory submissions across multiple jurisdictions, with no translation-related observations or deficiencies flagged during the review process. This helped accelerate market approvals and reduced the risk of launch delays due to language issues.

By incorporating automated label reuse, in-context QA, and early collaboration with stakeholders, Sesen helped the client reduce internal label QA review cycles by 35 percent. This optimization improved project velocity and reduced downstream rework.

Labeling consistency and clarity were significantly improved across all SKUs and packaging configurations. This enhanced the overall quality and usability of product labels for regulators, healthcare providers, and end users in each market.

Through this engagement, Sesen further strengthened its reputation as a trusted provider of end-to-end medical device labeling translation services, combining regulatory expertise, linguistic accuracy, and scalable delivery to meet the complex demands of global life sciences companies.

Why Sesen

Sesen brings a dedicated focus to medical device translation with deep specialization in regulatory labeling for in-vitro diagnostics, combination products, and complex medical technologies. Our teams understand the high stakes of product labeling and are equipped to manage multilingual compliance across global markets.

We offer proven expertise in IVD device labeling, multilingual desktop publishing (DTP), and in-context linguistic QA, backed by years of experience supporting leading medical device manufacturers. Our linguists and production teams are trained in the terminology, formatting, and regulatory nuances specific to diagnostic devices.

Sesen’s workflows are fully ISO 17100-compliant, with built-in quality assurance checkpoints to support EU MDR, IVDR, and international regulatory submission requirements. Each project benefits from structured validation processes, reviewer traceability, and secure documentation protocols.

Our use of integrated tools for terminology management, layout automation, and QA tracking ensures consistent delivery of print-ready and submission-ready label files. These tools support rapid revision cycles, efficient stakeholder reviews, and reduced risk of non-compliance.

Trusted by top global life sciences companies, Sesen consistently delivers high-volume, fast-turnaround multilingual labeling projects with a focus on precision, speed, and regulatory alignment. We act as an extension of our clients’ teams to provide scalable support and lasting quality outcomes.

Clinical Labeling Lead Perspective

Client feedback underscores Sesen’s value as a trusted language partner for high-stakes medical device labeling. A senior clinical labeling lead from the client’s regulatory team shared the following:

“Sesen helped us execute a high-visibility global launch with zero translation issues. Their ability to handle multilingual labeling and formatting across regions was critical to meeting our deadlines. The entire process was smooth, transparent, and well coordinated with our internal teams.”

This testimonial highlights Sesen’s strengths in managing multilingual complexity, ensuring regulatory accuracy, and maintaining on-time delivery in a global product launch environment.

Download the Full Case Study [PDF]

Access the complete case study to gain a deeper understanding of how Sesen supported a global IVD device manufacturer with high-volume multilingual labeling translation, desktop publishing, and linguistic QA. The downloadable PDF includes detailed information on project workflows, compliance strategies, regional adaptation methods, and measurable outcomes.

This resource is ideal for regulatory affairs professionals, quality managers, localization buyers, and procurement teams seeking proven partners for regulator-ready, multilingual labeling solutions. Use it to support vendor evaluations, internal presentations, or audit documentation.

DOWNLOAD CASE STUDY PDF DOWNLOAD CASE STUDY PDF

Related Services

Sesen provides a full range of specialized language services to support global product launches and regulatory submissions in the life sciences sector. Learn more about our related solutions:

  • Labeling Translation Services: Discover how Sesen delivers accurate, regulator-ready labeling translations for medical devices, pharmaceuticals, and diagnostics, aligned with regional compliance standards such as EU MDR and IVDR.
  • Multilingual Desktop Publishing (DTP): See how our expert DTP team adapts translated content for complex layouts and packaging constraints across multiple languages and file formats.
  • Regulatory Translation Services: Explore how Sesen supports global submissions with certified translations of IFUs, labels, SPCs, and other regulated content for FDA, EMA, and other health authorities.
  • Medical Device Translation: Learn how we help medical device companies launch products globally with linguistically precise and fully compliant translations across clinical, technical, and commercial content.

These services work together to provide end-to-end support for multilingual compliance, packaging readiness, and localization quality in the medical device industry.

Need Accurate, Regulator-Ready Label Translations?

Trust Sesen to deliver high-quality, compliant labeling and packaging translations tailored for global regulatory submissions. Our expert teams support over 150 languages with precision, speed, and full in-context validation.

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