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Why Medical Device Translation Style Guides Matter

Why Medical Device Translation Style Guides Matter

In the medical device industry, every word, symbol, and instruction carries regulatory and patient safety significance. A well-defined translation style guide provides the framework needed to standardize terminology, formatting, and safety communication across all device documentation. Without clear rules, even minor inconsistencies in instructions for use (IFUs), labeling, or technical specifications can create confusion for clinicians and patients, increase the risk of regulatory rejections, and delay market access.

Regulators in different regions, including the European Union’s MDR and IVDR and the United States FDA, require precise, consistent documentation for device approvals. These regulations extend to translated content, making consistency across languages critical. Errors in unit presentation, symbol usage, or safety statements can lead to compliance failures, costly resubmissions, or even patient harm.

Translation style guides ensure that multilingual IFUs, software user interfaces, and packaging are aligned with ISO and IEC standards, while also being clear and usable for global audiences. They define rules for terminology, warnings, abbreviations, and formatting, reducing variability across translators and projects. This consistency not only strengthens compliance with MDR, IVDR, and FDA expectations but also improves readability, reduces risks, and accelerates approvals in multiple markets.

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Key Elements of a Medical Device Translation Style Guide

Key Elements of a Medical Device Translation Style Guide

A medical device translation style guide defines the rules that ensure every piece of documentation is consistent, accurate, and compliant with global regulatory requirements. These elements help maintain quality across IFUs, labeling, packaging, and device software while supporting MDR, IVDR, and FDA submissions.

Incorporates internationally recognized frameworks such as ISO 15223 for medical device symbols and IEC 60601 for safety terminology. These standards ensure that safety instructions, icons, and compliance markings are translated and presented consistently across all languages.

Establishes formatting requirements for product names, device identifiers, dosage units, and multilingual packaging content. Consistency in these elements reduces regulatory queries and ensures patient-facing materials are clear and legally compliant.

Provides rules for standardized safety phrases, warnings, and instructions written at appropriate readability levels. By aligning IFU translations with MDR and FDA readability expectations, style guides improve patient comprehension and reduce liability risks.

Defines the correct presentation of SI units, calibration values, tolerances, and measurement ranges. Standardizing how technical data is translated prevents errors that could compromise device performance or patient safety.

Specifies terminology conventions for embedded software, user interface elements, error messages, and digital prompts. This ensures that device software remains intuitive and consistent for global users, even when localized into multiple languages.

Harmonizes the translation of warnings, contraindications, and precautionary statements. Standard phrasing helps clinicians and patients interpret safety information accurately across markets, while reducing the risk of regulatory rejection.

Together, these elements form the foundation of a medical device translation style guide that strengthens compliance, enhances usability, and accelerates international approvals.

Sample Excerpt from Our Medical Device Translation Style Guide

Sesen’s medical device translation style guide defines clear rules for consistency across IFUs, labeling, packaging, and device software documentation. The excerpt below illustrates practical examples such as symbol standardization and IFU formatting, showing how structured guidance supports compliance with MDR, IVDR, FDA, and ISO requirements.

Symbol Usage Standards

  • ISO 15223-1 symbols must be used consistently across all documentation and translated according to regional requirements.
  • Symbols should never be replaced with text equivalents unless explicitly required by regulators.
  • Placement must follow MDR and FDA guidance, ensuring symbols appear in proximity to related content.
  • Avoid modifying proportions, colors, or line thickness to preserve recognizability across markets.
 

Abbreviation and Acronym Rules

  • First-use expansion: Always spell out the full term followed by the abbreviation in parentheses on first use. Example: adverse drug reaction (ADR).
  • Consistency: Use the approved abbreviation list provided in the glossary to avoid variability across documents.
  • Pluralization: Add an “s” without an apostrophe when pluralizing abbreviations (e.g., ADRs).
  • Patient-facing documents: Avoid or limit abbreviations; use full terms wherever possible for readability.
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Use Cases in Medical Devices

Medical device translation style guides provide structured rules that apply across all types of device documentation, ensuring clarity, compliance, and consistency in every language. Below are common application areas where style guides deliver measurable value.

MDR technical documentation, IVDR labeling requirements, and FDA 510(k) submissions demand precise terminology and formatting. Style guides help standardize device names, safety language, and technical data, reducing the risk of regulatory queries and approval delays.

Consistent rules for multilingual carton text, leaflets, and UDI labeling are essential for market access. A style guide ensures uniform presentation of product identifiers, dosage or measurement units, and ISO symbols across packaging, supporting compliance with both EU and US device regulations.

IFUs, quick start guides, and training manuals must be written in clear, accessible language to protect patient safety. Style guides define readability levels, standardized safety warnings, and terminology rules that make instructions easy to follow across global markets.

Embedded interfaces, companion apps, and monitoring systems require consistent translation of on-screen prompts, error messages, and navigation terms. Style guides ensure user interfaces remain intuitive while meeting regulatory expectations for usability in multiple languages.

Promotional labeling, product brochures, and sales materials must balance commercial objectives with strict compliance requirements. A style guide aligns tone, terminology, and formatting so marketing content supports brand identity without introducing regulatory risks.

By applying these rules across submissions, labeling, patient documentation, and digital interfaces, medical device companies can accelerate approvals, reduce translation variability, and safeguard patient outcomes worldwide.

Why Partner with Sesen for Medical Device Translation Style Guides

Why Partner with Sesen for Medical Device Translation Style Guides

Sesen provides specialized expertise in developing and applying medical device translation style guides that meet the highest regulatory and linguistic standards. Our approach combines regulatory knowledge, certified processes, and advanced translation technologies to deliver consistent, compliant content across all device documentation.

Our teams have extensive experience with MDR and IVDR requirements in the European Union, FDA submissions in the United States, and ISO 13485 standards for medical devices. This knowledge ensures that translation style guides align with the expectations of global regulators.

Sesen operates under ISO 17100, ISO 9001, and ISO 13485 certifications, providing proven frameworks for translation quality, risk management, and compliance. These standards support accuracy across IFUs, labeling, packaging, and software documentation.

We support translation into 150 languages using professional native translators with specialized expertise in medical device terminology. This global network enables consistent quality across multilingual submissions and patient-facing materials.

Our hybrid approach integrates translation memory, terminology management, and machine translation post-editing (MTPE) when appropriate. This ensures consistency, accelerates turnaround times, and optimizes cost-efficiency without compromising quality.

By standardizing language and formatting, our style guides reduce variability across projects, safeguard patient safety, and minimize the risk of regulatory rejection or delay.

Sesen’s advantage lies in combining regulatory compliance with linguistic precision, making us a trusted partner for global medical device companies.

Download the Full Medical Device Translation Style Guide

Download the Full Medical Device Translation Style Guide

Access the complete style guide to see how Sesen standardizes translations for MDR, IVDR, and FDA compliance. The guide includes detailed frameworks for IFUs, labeling, packaging, and device software to help you achieve consistency and reduce regulatory risk.

DOWNLOAD FULL STYLE GUIDE

Explore More Resources

Medical device translation style guides are part of a larger framework of standards and services that support global compliance. The resources below provide additional insight into how Sesen ensures accuracy, consistency, and regulatory alignment across the life sciences.

By connecting style guide development with translation services and certified workflows, Sesen provides an integrated approach to medical device compliance in every market.

Talk to Us About Your Medical Device Translation Style Guide Needs

Ensure your medical device documentation meets MDR, IVDR, and FDA requirements with consistent, high-quality translations. Sesen helps global manufacturers streamline IFUs, labeling, packaging, and device software to support compliance and patient safety in every market.

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