MEDICAL DEVICES
Translate and maintain complex medical device technical documentation across languages, markets, product revisions, and regulatory environments.
Sesen combines specialized life sciences linguists, controlled terminology, professional review, translation memory, multilingual production, and AI-enabled quality workflows to help keep technical evidence consistent throughout the device lifecycle.
CONNECTED TECHNICAL EVIDENCE
Medical device technical documentation is not a collection of isolated files. It is an interconnected body of evidence describing what a device is, how risks are controlled, how safety and performance are demonstrated, and how the product continues to evolve after launch.
A change to intended purpose, software, risk controls, clinical evidence, manufacturing, or post-market findings can affect multiple controlled documents. Sesen helps preserve the terminology and technical meaning that connect those documents across languages.
Sesen translates technical documentation for medical devices, in vitro diagnostics, software-driven devices, connected technologies, and other regulated device products. The exact scope depends on the device, intended use, regulatory pathway, target market, and program requirements.
Establish consistent multilingual terminology at the foundation of the product record.
Preserve precise relationships between hazards, controls, residual risks, benefits, warnings, and supporting evidence.
Translate detailed engineering, scientific, software, testing, and validation evidence with subject-matter context.
Keep clinical evidence aligned with the device’s intended purpose, risk profile, safety, performance, and labeling.
Synchronize technical documentation with software functionality, version releases, risk controls, and digital product terminology.
Support controlled multilingual documentation across global quality, manufacturing, supplier, and operational environments.
Maintain continuity as new safety, performance, clinical, and corrective-action evidence emerges after launch.
Translate the defined technical content needed for international registrations, conformity assessment, and regulatory interactions.
DEVICE LIFECYCLE
A global translation program should evolve with it. Sesen helps carry approved terminology, language assets, and reviewer decisions forward as documentation changes.
Device definition, intended purpose, specifications, design records
Risk management, verification, validation, performance evidence
Clinical evidence, technical documentation, regulatory review
IFU, labeling, software, installation, training
PMS, PMCF, vigilance, clinical and safety updates
Updated technical evidence and controlled multilingual revisions
GLOBAL REGULATORY ENVIRONMENTS
Medical device language requirements are not identical across markets. They can vary by jurisdiction, device class, intended user, document type, conformity-assessment route, registration pathway, competent authority, notified body, and national language rules.
Sesen structures multilingual execution around the manufacturer’s defined markets and documentation requirements rather than applying a one-size-fits-all language model.
Regulatory Translation ServicesSupport technical documentation, clinical and performance evidence, risk content, IFUs, labeling, software documentation, and other defined materials for European programs and review pathways.
Support multilingual quality and technical documentation for FDA-regulated manufacturers, including content managed within QMSR and ISO 13485-based quality systems.
Support manufacturer-defined programs involving Health Canada, PMDA, ANVISA, NMPA, and additional regulatory environments across Asia-Pacific, Latin America, the Middle East, and other markets.
TERMINOLOGY GOVERNANCE
A product term should not gradually become five different terms as it moves from an engineering specification to a risk file, Clinical Evaluation Report, IFU, software interface, and post-market document.
Sesen can connect client glossaries, approved translations, translation memories, product references, style guidance, and reviewer decisions so the same underlying product concepts remain aligned across document types and languages.
CONTROLLED DOCUMENT REVISIONS
When Revision 4.2 replaces Revision 4.1, previously approved multilingual content should not automatically be treated as new. Sesen uses controlled content reuse and version-management workflows to focus translation and review effort where the source actually changed.
Previously translated and reviewed content forms the baseline.
Changed text, terminology, tables, specifications, and warnings are isolated.
Previously approved translation is reused where appropriate.
New and modified content is reviewed in the context of the existing documentation.
Terminology, numbers, completeness, formatting, and references are reviewed.
The new multilingual revision becomes the baseline for future updates.
Every project is configured according to document type, languages, intended use, risk, file format, regulatory context, approved language assets, and client quality requirements.
The goal is not simply to deliver a translated file. It is to create a multilingual documentation process that becomes more consistent and efficient over time.
Review source documentation, target languages, file formats, relationships, schedules, and existing language assets.
Identify important product, technical, clinical, safety, and regulatory terminology and align it with approved references.
Identify reusable approved content and changes between document revisions.
Assign qualified linguists according to language pair, content type, and medical-device subject matter.
Review meaning, terminology, completeness, technical consistency, and language quality when required by the workflow.
Check terminology, numbers, missing content, tags, consistency, formatting, and other machine-detectable issues.
Return translated content in the required format with attention to tables, graphics, expansion, scripts, and document structure.
Coordinate feedback from regulatory, quality, engineering, clinical, or in-country reviewers through a structured process.
Implement approved changes and complete defined linguistic and production checks before release.
Update terminology, translation memory, and approved language assets for future revisions and related documents.
Technology can improve consistency, reuse, workflow efficiency, and quality control, but it should be applied according to the content, risk, intended use, language pair, available assets, and client requirements.
Professional human expertise remains central to contextual language decisions and final quality.
Language, technical, medical, and regulatory judgment for complex content.
Reuse approved multilingual content across revisions, related documents, and product families.
Control product, engineering, clinical, safety, and regulatory vocabulary.
Support approved translation, terminology, and content-processing workflows where appropriate.
Help flag potential terminology, numeric, consistency, omission, and formatting issues.
Maintain human accountability for context, judgment, and final quality.
MULTILINGUAL PRODUCTION
Accurate language is only part of a usable multilingual technical document. Tables, cross-references, graphics, screenshots, controlled templates, and non-Latin languages can create substantial production challenges after translation.
Global portfolios may include device families, variants, accessories, software versions, manufacturing configurations, recurring safety language, and dozens of market languages.
Sesen can organize multilingual language assets at the program level so approved terminology and reusable content carry forward across related products, registrations, and revisions.
Feedback may come from Regulatory Affairs, Quality, Engineering, Clinical, local affiliates, distributors, and in-country subject-matter experts.
Sesen helps coordinate review with centralized feedback, clear change tracking, consolidated comments, terminology decisions, version control, and project-management oversight.
Technical-documentation translation requires a workflow that can preserve knowledge across documents, languages, reviewers, revisions, and years of product development.
Professional linguists support technical, clinical, regulatory, quality, software, and device-related content with the subject context each document requires.
ISO 17100, ISO 9001, and ISO 13485 support defined translation and quality-management processes.
Quality-sensitive workflows can include independent bilingual review by an additional qualified linguist.
Approved terminology, translation memory, references, and reviewer decisions can carry forward across related documents and revisions.
Support structured content, technical publishing formats, non-Latin languages, multilingual layout, and in-context QA.
AWS-hosted infrastructure and support across 150+ languages help scale recurring international medical device programs.
Answers to common questions about technical files, regulatory environments, version updates, terminology, AI-enabled workflows, and multilingual production.
Medical device technical documentation translation covers the specialized translation and multilingual management of documents describing a device’s design, intended purpose, risks, clinical evidence, verification and validation, manufacturing, software, quality processes, and post-market performance. A complete program may also include terminology management, translation-memory reuse, professional review, automated QA, version control, multilingual formatting, reviewer coordination, and final file validation.
Sesen supports device descriptions and specifications, design and manufacturing information, risk-management documentation, verification and validation records, Clinical Evaluation Reports, clinical evidence, software documentation, biological evaluation content, QMS documentation, PMS and PMCF materials, regulatory documentation, and other technical records. The exact workflow is configured according to the device, document type, language, intended use, regulatory context, and client requirements.
EU MDR establishes requirements for technical documentation and information supplied with medical devices, while language requirements vary according to the type of information, Member State requirements, conformity-assessment context, competent-authority requirements, notified-body requirements, and other factors. Manufacturers should determine the specific language requirements applicable to each market and regulatory pathway; Sesen then builds the translation workflow around those defined requirements.
Yes. Sesen supports multilingual medical device and IVD documentation for programs operating under EU MDR and EU IVDR, including technical documentation, clinical and performance evidence, risk documentation, IFUs, labeling, software-related content, and post-market materials. Translation scope and language requirements are defined according to the specific product, markets, documentation, and review pathway.
Sesen can maintain shared glossaries, terminology databases, translation memories, approved reference translations, style guidance, and reviewer decisions across related document types. These resources help preserve product, clinical, engineering, safety, and regulatory concepts while allowing language to remain appropriate for the audience and purpose of each document.
Sesen can compare updated source content with previous versions and use translation memory and controlled change workflows to identify new and modified content. Appropriate previously approved translations can be retained while changed content is translated and reviewed, and the updated release can become the baseline for future revisions.
Yes. Related devices often share terminology, specifications, warnings, components, software functions, and other technical content. Sesen can organize terminology and translation-memory assets across a product family so reusable approved content can support multiple devices, variants, languages, and future revisions.
Sesen uses a controlled, risk-based approach to AI and translation technology. Depending on document type, intended use, language pair, available approved content, client policy, and quality requirements, workflows may combine professional translation, translation memory, terminology intelligence, SesenGPT-assisted processes, automated QA, professional editing, and independent human review. Human expertise remains central to contextual decisions and final quality.
Sesen supports multilingual production across a wide range of technical-authoring and publishing formats, including Word, Excel, PowerPoint, InDesign, Illustrator, FrameMaker, XML, structured content, and PDF-based workflows. The production approach is defined according to the source format, target languages, required deliverables, and document complexity.
Yes. Accelerated workflows can be structured based on source volume, language count, existing translation-memory leverage, file complexity, professional-review requirements, and available resources. For updated documents, identifying changed content and reusing appropriate approved translation can reduce the amount of new content requiring translation and review.
Sesen supports more than 150 languages for international medical device programs, including European, Asia-Pacific, Latin American, Middle Eastern, African, non-Latin, and right-to-left language requirements. Multilingual production support can be configured around the source files, target markets, and documentation workflow.
Whether you are preparing documentation for a new market, updating an existing technical file, revising clinical evidence, responding to a review request, introducing a new product variant, or maintaining a global device portfolio, Sesen can build a controlled multilingual workflow around your program.
