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Medical Device Translation Services

Rapport International provides medical device translation in 200+ languages with ISO 17100 & ISO 13485–aligned workflows, covering IFUs, labels/e-labels, UDI, PMS/PMCF, CERs and software UIs. We map translations to EU MDR/IVDR language tables and FDA labeling guidance to speed approvals and audits.

Get Ready-to-Use Translated Materials Across All Mediums

 

✅ ISO-Certified Translation Services

We’re fully certified under ISO 13485, ISO 17100, and ISO 27001, meeting the highest international standards for quality, safety, and data security—critical for regulatory compliance and audits.

✅ Expert Medical Translators

Our linguists aren’t just native speakers—they’re subject-matter experts with backgrounds in biomedical, technical, and life sciences, reducing the risk of translation errors that could compromise patient safety or regulatory approval.

✅ Regulatory Expertise: MDR, IVDR, FDA & EMA

We specialize in medically regulated markets, including Europe and the U.S. Our team understands the nuances of MDR, IVDR, FDA, and EMA requirements, helping you avoid costly delays and compliance issues.

✅ Data Security & Confidentiality

We follow strict protocols aligned with HIPAA, GDPR, and ISO 27001, safeguarding sensitive patient data, device specifications, and proprietary materials throughout the translation process.

Why We're The Best Translation Partner for Medical Device Companies
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What is Medical Device Translation?

Medical device translation is the specialized process of accurately translating Instructions for Use (IFUs), labels, e-labels, software, packaging, and regulatory documentation into multiple languages to meet international compliance requirements and ensure patient safety.

This type of translation goes beyond words. It demands deep knowledge of medical terminology, ISO 13485 standards, MDR/IVDR regulations, and country-specific labeling laws. Errors in translation can lead to regulatory delays, product recalls, or harm to end users.

A trusted medical device translation partner ensures:

  • Linguistic and regulatory accuracy
  • Fast approvals from global health authorities
  • Clear, compliant documentation for global markets

Whether you're preparing for EU MDR submissions or launching devices across Asia or LATAM, medical device translation is essential for market access and brand integrity.


 

Why Accuracy Matters in Regulatory Submissions (MDR/IVDR)

Inaccurate translations in MDR (Medical Device Regulation) or IVDR (In Vitro Diagnostic Regulation) submissions can delay product approvals, trigger costly rework, or even result in market rejections and recalls.

Under MDR and IVDR, the European Union requires precise, harmonized, and localized documentation in each target market’s official language. This includes: 

Even minor translation errors can lead regulators to question product safety, device performance, or manufacturer reliability—jeopardizing your path to compliance.

Working with expert medical device translators ensures:

  • Full alignment with EU language requirements
  • Clear, consistent terminology across all documents
  • Fewer regulatory challenges and faster time-to-market

Accuracy isn’t optional—it’s critical for MDR/IVDR success.


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🔗 EU MDR Language Requirements (EU Commission)

🔗 EU IVDR Language Requirements (EU Commission)

🔗 FDA Medical Device Labeling Guidance

FAQ

Get answers to commonly asked questions.

Do we need translations for IFUs/labels under MDR/IVDR?

Yes. Both the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) require that Instructions for Use (IFUs), labels, and safety information be provided in the official language(s) of each EU member state where the device is marketed. This ensures patients, healthcare providers, and regulators can access critical information in their native language. Non-compliance can result in delayed approvals, product recalls, or market access restrictions.

Which countries/languages are mandatory?

Language requirements depend on the target market:

  • European Union: Each member state has specific rules. For example, Germany requires German, France requires French, and Belgium requires Dutch and French (sometimes German).
  • Switzerland & EFTA states: Generally align with EU requirements, but verify local guidance.
  • Other global markets (U.S., Canada, LATAM, Asia): Regulations vary—e.g., Canada requires English and French; China requires Simplified Chinese.

👉 The rule of thumb: regulatory and safety information must always appear in the official language(s) of the country where the device is sold.

Can you translate software UIs/e-IFUs?

Yes. We translate software user interfaces (UIs), e-IFUs, and digital labeling in compliance with MDR/IVDR. This includes on-screen menus, help files, patient-facing portals, and electronic IFUs. Our process ensures linguistic accuracy, regulatory compliance, and user-friendly terminology—critical for usability studies and CE marking.

What standards do your translators follow (ISO 17100, medical SME review)?

Our medical device translations follow the ISO 17100 quality standard, which requires:

  • Qualified, native-speaking translators with subject matter expertise.
  • Independent review by a second linguist.
  • Documented workflows and terminology management.

For highly technical or high-risk content, we also provide:

  • Medical Subject Matter Expert (SME) review to validate terminology.
  • Compliance with MDR/IVDR and FDA expectations.
Can you tell me about typical timelines & quality controls (TEP, back-translation, bilingual review)?
  • Timelines: Standard projects (e.g., labels, IFUs) are typically completed within 5–10 business days, while urgent requests can be expedited. Large CERs or PMS reports may take longer.
  • Quality Controls:
    • TEP (Translation, Editing, Proofreading) – every file passes through a three-step linguist workflow.
    • Bilingual Review – client or SME in-country review is supported.
    • Back-translation – available for high-risk documentation to verify accuracy word-for-word.
    • Terminology & Style Guides – customized to your products for consistency across markets.

Keep Learning

The Top 3 Translation Requirements in Medical Device Manufacturing

8 Translation Challenges Faced by Medical Device Companies

 Why Rapport International is the Best Translation Provider for Medical Device Companies

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services - launch (8)
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Unibloc pump

Very responsive, very accurate and well done translation!  Thank you! 

- CEO, Unibloc Pump

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gerson testimonial 100tall 2023

Our experience working with Rapport International has been excellent. Even with requests for large amounts of multiple language translations they’re always able to come through.

I've always recommended Rapport International to friends and colleagues and will continue to do so. 

- Creative Services Manager, Gerson

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Autostore

The team was great to work with - they were understanding of our needs and turned around our translation pieces quickly. 

- Marketing Content Manager, AutoStore

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berlin packaging

Rapport turns around quality work in record time. They are a key resource for our global company.

- Director of Marketing, Berlin Packaging

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ranfac

I so appreciate the great service. Ranfac has counted on Rapport International for over a decade and looks forward to our next project together. 

- EVP and GM, Ranfac