Navigating ISO 13485 Translation Requirements: A Comprehensive Guide for Medical Device Manufacturers

In the medical device industry, compliance with international standards is not just a legal obligation—it’s a strategic necessity that safeguards quality, patient safety, and global market access. ISO 13485 is the international standard for Quality Management Systems (QMS) specific to medical devices.

While ISO 13485 does not provide an explicit roadmap for translation, its clauses related to documentation, labeling, customer communication, and risk management imply requirements for accurate and controlled multilingual content. This blog explores those hidden—but critical—translation responsibilities and how manufacturers can align with them

Understanding ISO 13485: Why Translation Matters

ISO 13485:2016 specifies the requirements for a QMS that demonstrates an organization’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements. It is applicable to organizations involved in all stages of the medical device lifecycle.

For companies expanding into global markets, compliance means more than ticking a checkbox. It requires that product-related documents—labels, IFUs, customer support materials, and regulatory submissions—are available in the official languages of each target country. This is where translation becomes compliance-critical.

Clause 4.2.4 & 4.2.5: Translation in Document Control

While Clause 4.2.4 & 4.2.5 of ISO 13485 outlines the general requirements for document control, it directly impacts multilingual documentation:

• Translated documents (SOPs, IFUs, and Technical Files) must undergo the same control process as the source documents.
• Every translated version must be identifiable, reviewed, and traceable.
• Organizations must ensure that obsolete translations are withdrawn to avoid unintended use.

This is critical when product instructions are used across markets in different languages. If the original IFU is updated, the translated versions must be updated and redistributed—failure to do so is non-compliance.

Clause 5.6.2 & 7.2.1: Regional Regulatory Translation Requirements

ISO 13485 requires manufacturers to comply with applicable regulatory requirements, which often include language-specific mandates. Here’s a snapshot of how translation is legally required in key markets:

• European Union (EU): MDR mandates IFUs and labels in the official language(s) of each Member State.
• Canada: Health Canada requires English and French translations for all consumer-facing medical documents.
• Japan: The PMD Act mandates documents be in Japanese.
• China: The NMPA requires Simplified Chinese translations for registration documents and labeling.
• South Korea: MFDS mandates Korean-language labeling and product information.
• Brazil: ANVISA mandates Portuguese translations.
• Russia: Roszdravnadzor mandates Russian for all product documents.

Non-compliance can result in product rejections, delays in market entry, or legal consequences.

Clause 7.5.1 & 7.5.3.2.1: Translations of Labels and IFUs

Medical device labeling and instructions for use (IFUs) must be:

• Accurate and complete in all target languages
• Culturally appropriate and comprehensible to the intended user
• Designed for the user type (layperson vs. medical professional)

For all regions where the device is marketed and sold.

An incorrectly translated dosage, warning, or instruction can cause serious harm to users and lead to lawsuits or recalls.

Clause 7.1: Translation in Risk Management

Language is a hidden but major risk factor. Clause 7.1 requires manufacturers to:

• Assess risks related to incorrect or unclear translations
• Integrate translation quality into the overall risk management file
• Implement controls like:
• Using qualified medical translators
• Conducting back translations for high-risk content
• Reviewing translations by in-market subject matter experts (SMEs)

If your IFU is misunderstood due to poor translation, it’s a regulatory liability and a potential hazard.

Clause 7.2.3: Multilingual Customer Communication

ISO 13485 expects manufacturers to ensure effective customer communication across all regions. This includes:

• Translated product guides, warranty information, and troubleshooting FAQs
• Local-language complaint forms and return instructions
• Multilingual customer support emails or chatbots

Companies must ensure that language doesn’t become a barrier to safety, usability, or trust.

Clause 7.5.11: Preservation of Translated Content

Preservation goes beyond physical packaging. ISO 13485 requires that the content—especially translated labels and IFUs—remains:

• Legible through the entire product lifecycle
• Resistant to fading, smearing, or loss due to packaging materials or environmental exposure
• Correct in context and language, even after years of storage

Failing to preserve language integrity can compromise compliance even after distribution.

Also read: Fastest Growing Medical Device Markets & Need For Translation

Best Practices for ISO 13485-Compliant Translation

To truly meet ISO 13485 expectations, manufacturers must treat translation like any other regulated process.

1. Align with ISO 17100:2015 – The Translation Standard

ISO 17100 sets global standards for translation service providers. Working with an ISO 17100-certified LSP ensures:

• All linguists meet formal education and domain training requirements
• Translation projects follow documented QA workflows
• Traceability is maintained from initial brief to final delivery

2. Build a Strong Translation Ecosystem

• Translation Memory (TM): Ensures consistency and reduces cost/time for repeat content
• Terminology Glossaries: Aligns all language with approved clinical/legal terms
• Style Guides: Tailors tone, voice, and structure per language and region

3. Work Only with Qualified Medical Translators

• Linguists should be native speakers with proven medical/life sciences expertise
• Use SMEs or regulatory consultants for high-risk reviews
• Apply back translation and reconciliation for product-critical content

4. Establish a Translation Quality Management System (TQMS)

• Record all translator qualifications, QA steps, and version approvals
• Link translations with your QMS and document control platforms
• Create an audit-ready trail for all translated materials

5. Conduct Periodic Translation Risk Reviews

• Include translation failure modes in your FMEA or risk files
• Audit external LSPs for compliance readiness
• Train your internal RA/QA teams to evaluate multilingual risks

Also read: Quality Assurance In Medical Device Translations

Why Milestone Localization is the Right Partner for ISO 13485 Compliance

At Milestone Localization, we understand the stakes of getting translations right in the medical device industry. That’s why we’ve built our processes to align with the highest international standards — not just in words, but in practice.

We are proud to be certified in:

• ISO 13485:2016 – for quality management systems specific to providing translations for medical device documentation
• ISO 17100:2015 – for high-quality translation services, ensuring qualified linguists, traceable workflows, and documented quality control
• ISO 9001:2015 – for general quality management systems. These certifications reflect our commitment to helping medical device manufacturers meet both regulatory requirements and real-world user expectations.

With a specialized team of native-speaking medical translators, robust translation memory systems, and audit-ready quality documentation, we are uniquely positioned to support:

• EU MDR and IVDR compliance
• Global market entry with multilingual labeling and IFUs
• ISO 13485 documentation translations

Partnering with Milestone means partnering with a truly specilialised medical device translation partner who understands the importance of accuracy, traceability, accountability and quality.

Conclusion: Translation is a Core Pillar of ISO 13485 Compliance

Translation isn’t just about converting content — it’s about maintaining safety, regulatory alignment, and patient trust across every market you enter. Poor translation is not just a cost center; it’s a business risk and a compliance failure waiting to happen.

By working with a qualified, ISO 17100-certified Language Service Provider (LSP), medical device manufacturers can:

• Lower compliance risks
• Streamline audits
• Improve global user experiences
• Enhance patient safety

When translation is treated with the same rigor as engineering or clinical validation, it becomes a force multiplier—not a compliance afterthought.

Also read: Medical Translation Agency: How To Choose The Right One?