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ISO 13485-Compliant Medical Device Translations

ISO 13485 is the globally recognized quality management standard for medical device manufacturers, covering all stages of the product lifecycle from design to post-market surveillance. For companies operating internationally, the standard’s rigorous requirements extend to translated documentation, where accuracy, consistency, and regulatory compliance are non-negotiable.

Language errors in labeling, Instructions for Use (IFUs), technical files, or regulatory submissions can lead to non-compliance, costly delays, or product recalls. An ISO 13485-aligned translation process ensures that all multilingual content meets the same quality management system (QMS) controls applied to the device itself.

Sesen holds ISO 13485 certification, demonstrating our adherence to documented procedures, risk management practices, and traceability standards that meet the highest regulatory expectations. Our certified workflows combine professional native medical device translators, subject matter expertise, and stringent QA protocols to deliver accurate, audit-ready translations for every target market.

What Is ISO 13485 and Why It Matters for Translation

What Is ISO 13485 and Why It Matters for Translation

ISO 13485 is the internationally recognized quality management standard specifically designed for medical device manufacturing. It outlines the requirements for a quality management system (QMS) that ensures devices consistently meet customer needs and regulatory requirements throughout their lifecycle. The standard covers design, production, installation, and servicing, and it places strong emphasis on documentation accuracy, risk management, and product traceability.

These requirements extend to multilingual documentation. Under ISO 13485, translated materials such as Instructions for Use (IFUs), labels, technical files, and regulatory submissions must be produced and managed under the same QMS controls as the source content. This includes strict version control, validation of translator qualifications, adherence to approved terminology, and detailed record-keeping for audit purposes.

Regulatory authorities worldwide, including those enforcing the EU Medical Device Regulation (MDR), the U.S. Food and Drug Administration (FDA), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Australia’s Therapeutic Goods Administration (TGA), recognize ISO 13485 as a benchmark for compliance. In these markets, failure to meet translation requirements can result in delayed product launches, rejected submissions, or even product recalls.

Accurate, ISO 13485-compliant translations protect patient safety, support faster approvals, and maintain your company’s compliance record across all markets.

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Medical Device Content We Translate Under ISO 13485

Medical Device Content We Translate Under ISO 13485

Sesen provides ISO 13485-compliant translations for a wide range of medical device documentation, ensuring accuracy, consistency, and full regulatory alignment in every target market. Our workflows maintain strict version control, apply approved terminology, and follow documented quality procedures to meet the requirements of global regulatory bodies.

We translate the following content under ISO 13485 quality standards:

  • Instructions for Use (IFUs) – Clear, compliant translations to meet regional labeling and usability requirements.
  • Device labels and packaging – Accurate, regulator-approved content for all languages and markets.
  • Technical files and product specifications – Multilingual documentation for device design, manufacturing, and performance validation.
  • Quality management system (QMS) documents – Policies, procedures, and SOPs aligned with ISO 13485 and internal audit requirements.
  • Clinical evaluation reports (CERs) – Translations that maintain scientific accuracy and regulatory format for EU MDR and other jurisdictions.
  • Regulatory submissions – Market-specific translations for EU MDR applications, U.S. FDA 510(k) submissions, and PMA filings.
  • Risk management documentation (ISO 14971) – Multilingual content supporting hazard identification, risk analysis, and mitigation strategies.
  • Marketing and training materials for medical devices – Professionally translated content for global sales teams, distributors, and healthcare professionals.
  • Digital content and software interfaces for devices – Localization of user interfaces, mobile applications, and digital instructions to meet usability standards.
Our ISO 13485-Compliant Translation Process

Our ISO 13485-Compliant Translation Process

Sesen follows a rigorous, documented workflow that meets ISO 13485 and ISO 17100 requirements, ensuring every translated medical device document is accurate, consistent, and audit-ready. For critical content like Instructions for Use (IFUs) and device labels, our process adds extra controls to meet usability, readability, and regulatory formatting standards.

  • Assess source documents to identify content type, regulatory scope, and market-specific requirements.
  • Map translation deliverables to ISO 13485 QMS procedures and applicable regulatory frameworks such as EU MDR, FDA, PMDA, and TGA.
  • Assign professional native translators with proven medical device subject matter expertise.
  • Verify translator qualifications, experience, and adherence to ISO 13485 and ISO 17100 standards.
  • Develop and maintain client-approved glossaries to ensure consistent terminology across all languages.
  • Leverage translation memory technology to maintain accuracy, improve efficiency, and reduce costs over time.
  • Conduct independent bilingual reviews to confirm linguistic accuracy and technical precision.
  • Implement in-country reviews when required to meet local regulatory or usability expectations.
  • Format translated content to comply with device labeling, IFU, and packaging requirements in each target market.
  • Ensure multilingual layouts maintain readability and regulatory compliance.
  • Perform a final ISO 13485 compliance audit of all deliverables.
  • Apply version control and documentation management for full audit readiness.
  • Deliver files in the required formats, ready for regulatory submission or market release.
  • Perform a final ISO 13485 compliance audit of all deliverables.
  • Apply version control and documentation management for full audit readiness.
  • Deliver files in the required formats, ready for regulatory submission or market release.
  • Perform a final ISO 13485 compliance audit of all deliverables.
  • Apply version control and documentation management for full audit readiness.
  • Deliver files in the required formats, ready for regulatory submission or market release.
  • Perform a final ISO 13485 compliance audit of all deliverables.
  • Apply version control and documentation management for full audit readiness.
  • Deliver files in the required formats, ready for regulatory submission or market release.
  • Perform a final ISO 13485 compliance audit of all deliverables.
  • Apply version control and documentation management for full audit readiness.
  • Deliver files in the required formats, ready for regulatory submission or market release.
Benefits of Working With Sesen for ISO 13485 Translations

Benefits of Working With Sesen for ISO 13485 Translations

Partnering with Sesen ensures your medical device translations meet the highest quality, compliance, and industry standards. Our ISO-certified workflows, life sciences expertise, and global capabilities position us as a trusted partner for manufacturers seeking seamless international market entry and growth.

Our advantages include:

  • Certified Quality Management Systems – Fully certified to ISO 13485:2016, ISO 17100, and ISO 9001:2015, ensuring every translation follows documented procedures, risk management protocols, and traceability controls recognized worldwide.
  • Regulatory Expertise Across Key Markets – In-depth knowledge of EU MDR, U.S. FDA submission requirements, Health Canada, PMDA Japan, TGA Australia, and other global regulatory frameworks to ensure approval-ready content.
  • Risk-Mitigated Workflows – Structured processes with multistep review, terminology control, and audit-ready documentation designed to prevent costly compliance failures and product launch delays.
  • Scalable Multilingual Capacity – Ability to manage large, complex, and multi-language rollouts without compromising accuracy or regulatory compliance.
  • 100% Life Sciences Focus – Deep specialization in medical devices, pharmaceuticals, biotechnology, and healthcare, ensuring translators and reviewers understand the technical and regulatory context of your content.
ISO 13485-Compliant Translations for Global Market Expansion

Case Study: ISO 13485-Compliant Translations for Global Market Expansion

A leading medical device manufacturer engaged Sesen to translate its Instructions for Use (IFUs), device labeling, and technical documentation for simultaneous market launches in the European Union, Canada, and Japan. The project required strict adherence to ISO 13485:2016 and EU MDR requirements, with additional formatting and terminology compliance for Health Canada and PMDA Japan submissions.

Sesen implemented its ISO 13485-certified translation process, including professional native medical device linguists, client-approved glossaries, in-country regulatory reviews, and full documentation control for audit readiness. By applying risk management protocols and version control at every stage, the translations met both linguistic and regulatory specifications without requiring corrective action.

Results:

  • Reduced regulatory review time by 30% through consistent terminology and submission-ready formatting.
  • Achieved zero non-compliance findings during audits and product registration reviews.
  • Delivered all multilingual files on time, enabling coordinated market entry without launch delays.

This project demonstrates how Sesen’s certified workflows and life sciences expertise help manufacturers achieve faster approvals and maintain a flawless compliance record in highly regulated markets.

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Related Services

Sesen provides a full range of life sciences translation solutions to support every stage of the medical device lifecycle. Our ISO-certified processes, subject matter expertise, and global network of professional native translators ensure your multilingual content meets the highest regulatory and quality standards.

Explore our related services:

By integrating these services, Sesen helps manufacturers streamline multilingual workflows, reduce review cycles, and maintain compliance across global markets.

ISO 13485 Translation FAQs

ISO 13485 is the international quality management standard for medical device manufacturing, covering all processes that affect product safety and regulatory compliance, including translation. ISO 17100 is the translation-specific standard that defines requirements for translator qualifications, review steps, and project management. At Sesen, our workflows comply with both standards, ensuring medical device translations meet the highest quality and regulatory benchmarks.

Yes. We provide formal Certificates of Accuracy or Statements of Translation for regulatory authorities such as the EU MDR, U.S. FDA, Health Canada, PMDA Japan, and TGA Australia. These certificates confirm that the translation is complete, accurate, and produced under ISO-certified processes.

Yes. Our scalable teams and technology-assisted workflows allow us to accelerate delivery without bypassing critical ISO 13485 controls such as terminology management, bilingual review, and version tracking. This ensures urgent projects are both fast and fully compliant.

We apply EU MDR-specific terminology control, formatting checks, and layout reviews for all labeling and Instructions for Use (IFUs). Our process includes in-country review when needed to verify compliance with local language regulations before final delivery.

Yes. We collaborate with client-appointed in-country reviewers, affiliates, or regulatory consultants to ensure translations are accurate, market-appropriate, and regulator-ready. All reviewer feedback is documented and integrated into our controlled quality management system for full traceability.

Start Your ISO 13485 Translation Project

Bring your medical device documentation to global markets with confidence. Sesen’s ISO 13485-certified translation services combine life sciences expertise, native-language precision, and strict regulatory compliance to ensure your content is audit-ready in every language.

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