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Trusted Certified Translations for Global Medical Device Compliance

Trusted Certified Translations for Global Medical Device Compliance

Sesen provides certified medical device translation services tailored for regulatory affairs, quality assurance, and clinical submission teams. Our ISO 13485 and ISO 17100 certified workflows support multilingual compliance with FDA, EU MDR, IVDR, and other international requirements. Every translation is completed by qualified subject matter experts and backed by full audit trails, translator credentials, and certification letters upon request. Whether for 510(k) filings, CE technical files, or global labeling, Sesen delivers accurate, submission-ready translations that meet the highest regulatory standards.

Why Certification Matters

Certified translations play a critical role in medical device submissions for FDA, EU MDR, IVDR, and other global regulatory frameworks. Regulatory agencies require linguistic accuracy, traceable documentation, and translator qualifications to validate the integrity of translated content. Submissions with errors or uncertified translations may face delays, rejections, or noncompliance findings during audits or technical file reviews. In the life sciences context, a certified translation includes validated translator credentials, documented review steps, and an official statement of accuracy. Sesen ensures every certified deliverable meets these stringent expectations with full audit support.

What’s Included in a Certified Translation Package

Sesen delivers certified medical device translations with comprehensive documentation to meet regulatory and quality assurance requirements. Each certified package includes translations performed by native-speaking subject matter experts with verified experience in medical device terminology. A signed certificate of accuracy is provided with every submission, along with translator CVs and qualifications upon request.

Our certified process also includes a full audit trail with version history for traceability, multilingual formatting aligned with labeling and IFU requirements, and optional back translation with reconciliation. Certification letters can be prepared to support notified body reviews or agency audits, ensuring your documentation is complete and compliant across all target markets.

Regulatory Frameworks We Support

Regulatory Frameworks We Support

Sesen provides certified medical device translations that align with the regulatory submission standards of key global markets. Our ISO-certified workflows support region-specific documentation formats, terminology, and compliance protocols to ensure your translated content meets all applicable regulatory expectations.

We support:

  • United States: Translations for FDA 510(k), PMA, and De Novo submissions, including labeling, IFUs, and risk documentation
  • European Union: Full language support for EU MDR and IVDR compliance, including CE Marking documentation, SSCPs, and technical files
  • Canada: Certified translations for Health Canada licensing, labeling, and device registration
  • Asia: Market-specific services for Japan (PMDA), South Korea (MFDS), and China (NMPA), including country-specific linguistic validation and formatting

Our approach also aligns with global harmonization standards such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Task Force (GHTF), helping you streamline submissions across multiple jurisdictions with consistent, audit-ready deliverables.

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Document Types That Require Certification

Document Types That Require Certification

Certified translations are required for a wide range of regulatory-critical documents in the medical device industry. These materials must meet stringent standards for accuracy, consistency, and traceability to support approval, labeling, and market surveillance across global jurisdictions. Sesen provides certified translations for the following document types:

Certified translations of IFUs are required for safe and effective device use across international markets. Sesen localizes content in accordance with regional labeling regulations and readability requirements for end users and patients.

We translate comprehensive design and manufacturing documentation for CE Marking, including device descriptions, manufacturing protocols, labeling, and clinical data, ensuring consistency across all target languages.

Sesen delivers certified translations for FDA 510(k) premarket notifications, including summaries, device comparisons, and supporting clinical and labeling materials, formatted to meet FDA reviewer expectations.

Our team supports all language components of CE Marking applications, including conformity declarations, Essential Requirements checklists, and supporting safety documentation, aligned with MDR guidelines.

We translate and certify patient-facing materials that must be accurate, culturally appropriate, and easy to understand. These include leaflets required for Class IIb and Class III devices under EU MDR.

Sesen provides certified translations of CERs to support technical file submissions in Europe. Our linguists maintain medical precision and structural integrity for notified body review.

We translate SSCPs into all required EU languages with a focus on clarity, public accessibility, and alignment with manufacturer claims and supporting documentation.

Our certified translations cover periodic safety update reports (PSURs), vigilance reports, and field safety notices, helping clients meet post-market regulatory obligations globally.

Sesen translates detailed risk analysis documents, including hazard identification, risk estimation, and mitigation strategies, ensuring technical accuracy and compliance with ISO 14971 standards.

Each document is translated by qualified linguists and delivered with certification and audit-ready formatting to meet local authority expectations.

Our Certified Translation Process

Our Certified Translation Process

Sesen follows a structured, ISO 13485 and ISO 17100 certified workflow designed to produce fully compliant, audit-ready translations for global medical device submissions. Each step in our process is traceable, quality controlled, and aligned with regulatory expectations.

We begin by evaluating your source files, target languages, and submission requirements. Our team identifies document types, regulatory jurisdictions, and any special formatting or compliance needs.

Certified translators are selected based on native language fluency and subject matter expertise in medical devices. Credentials and relevant qualifications are validated prior to project assignment.

Translations are performed by professional linguists with proven experience in regulatory, clinical, and technical medical device content. Terminology is aligned with approved glossaries and labeling standards.

A second linguist performs a full review to ensure accuracy, consistency, and adherence to regulatory terminology. Edits are tracked for transparency and audit purposes.

For high-risk or patient-facing content, we provide optional back translation and reconciliation to confirm equivalence between source and target texts.

Each file undergoes final quality control, including formatting verification and terminology validation. A signed certificate of accuracy and translator credentials are prepared as needed.

Deliverables are finalized with version history, metadata, and full documentation. Files are delivered in the required multilingual format, ready for immediate inclusion in regulatory submissions.

Why Choose Sesen

Why Choose Sesen for Certified Medical Device Translation

Sesen delivers certified medical device translations with a strong foundation in regulatory compliance, technical accuracy, and operational transparency. Our services are trusted by global manufacturers for multilingual submissions across North America, Europe, and Asia.

Our certified workflows meet international standards for medical device quality management and translation service delivery.

We assign linguists with verified subject matter expertise in medical technology, diagnostics, and regulatory documentation.

All project data is managed within a secure, HIPAA-compliant environment hosted on Amazon Web Services.

We support 510(k), PMA, CE Mark, and EU MDR/IVDR documentation across a range of device classes and therapeutic areas.

Clients benefit from detailed project visibility, QA checkpoints, and documented version control throughout the translation cycle.

We provide signed certificates of accuracy, translator credentials, and supporting letters that meet the documentation standards of specific regulatory bodies and notified authorities.

Client Use Cases

Client Use Cases

Sesen has supported global medical device companies with certified translations for high-impact regulatory submissions and compliance documentation. Below are examples of recent projects that demonstrate our expertise in certified medical device translation:

Certified translation of technical documentation, labeling, and risk analysis reports for a Class II device submitted to the FDA across five languages.

Full translation and certification of technical files, design dossiers, and clinical data to support CE Marking under EU MDR requirements.

Localization and certification of multilingual UI strings, safety warnings, and user documentation for a regulated digital health solution targeting European and APAC markets.

Regulatory-compliant translation of Instructions for Use into 24 EU languages, complete with glossary alignment, back translation, and signed certificates of accuracy.

Each project was completed using our ISO-certified workflows, with translator qualifications, audit trails, and submission-ready formatting tailored to client and authority requirements.

FAQs About Certified Medical Device Translations

A certified medical device translation includes a signed statement confirming the translation is complete and accurate to the best knowledge of the translator or agency. It is performed by qualified linguists with documented subject matter expertise and includes audit-ready deliverables such as translator credentials, version history, and certificates of accuracy.

Yes. Most regulatory agencies, including the FDA, notified bodies in the EU, and Health Canada, may request or require certification documentation during submission reviews. This can include a certificate of accuracy, translator CVs, and details of the quality assurance process used for the translation.

Yes. Sesen offers optional back translation and reconciliation services for high-risk documents such as patient-facing materials, clinical evaluations, and informed consent forms. This process enhances verification and is often required by ethics committees or notified bodies for sensitive content.

Turnaround times depend on the document type, word count, and target languages. However, Sesen offers expedited timelines for urgent regulatory needs while maintaining full compliance with ISO-certified processes. Project schedules are always discussed and confirmed during project intake.

Sesen supports certified medical device translations in over 100 languages, including all official EU languages, Chinese (Simplified and Traditional), Japanese, Korean, Arabic, Russian, and Latin American Spanish. We maintain a global network of prequalified medical device linguists across all major markets.

Yes. Our linguists are selected based on demonstrated experience in medical device translation and undergo continuous training on ISO 13485 principles, terminology management, and regulatory documentation requirements to ensure every translation meets global compliance standards.

Related Services

Sesen offers a full range of specialized translation and localization services to support every stage of the medical device product lifecycle. Explore our related solutions to ensure your documentation meets regulatory, linguistic, and formatting requirements across global markets:

  • Comprehensive language support for clinical, technical, and regulatory content across all device classes and target markets.
  • Accurate, user-friendly translations of Instructions for Use tailored to region-specific formatting and labeling standards.
  • Language solutions aligned with the European Medical Device Regulation, including CERs, SSCPs, and technical documentation.
  • Certified translations of CERs prepared for notified body review, maintaining terminology integrity and submission readiness.
  • Final-stage quality assurance for translated labeling and packaging, using real-time in-context validation to eliminate errors before regulatory filing.

Ready for Compliant, Certified Medical Translations?

Partner with Sesen for certified medical device translations that meet global regulatory standards and accelerate your market approvals. Whether you need support for a 510(k), CE Mark, or MDR submission, our team is here to help.

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