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ISO 15223-1 symbols referenced- Character length fits label width
- Terminology matches glossary
Medical Device Labeling Translation Services — ISO 13485 Certified
Deliver accurate, compliant multilingual labeling for global medical device markets with Stepes’ ISO 13485–certified translation services. From IFUs and packaging inserts to UDI documentation and e-labeling, our solutions safeguard patient safety, meet regulatory requirements, and accelerate international market approvals.
Certified in ISO 13485, ISO 17100, and ISO 9001
Specialized in EU MDR, FDA 21 CFR Part 801, and global device labeling compliance
Translations by professional native linguists with medical device expertise
Support for 100+ languages with audit-ready documentation
Why Accurate Medical Device Labeling Translation Matters
The risks of mistranslation in device labeling
Errors in translated labeling can have serious consequences, from incorrect device usage to patient injury. Mistranslations may cause regulatory authorities to issue recalls, delay approvals, or impose fines. They also create liability risks for manufacturers and can damage brand reputation in global markets. For medical device companies, precise multilingual labeling is not optional but a critical compliance requirement.
Patient safety and regulatory clearance challenges
Regulators such as the FDA, European Commission under MDR, and health authorities in Asia and Latin America require labeling to be clear, accurate, and available in local languages. Incomplete or inaccurate translations can compromise patient safety by leading to misuse or misunderstanding of device instructions. They also jeopardize regulatory clearance by triggering noncompliance findings during audits or product submissions. High quality medical device labeling translations safeguard patient outcomes, support clinical efficacy, and enable timely approvals in global markets.
Stepes’ ISO 13485-Certified Translation Process
Accurate medical device labeling requires more than linguistic skill. It demands a structured workflow that complies with international quality standards. Stepes applies an ISO 13485-certified translation process designed to meet the strict regulatory expectations of global health authorities while ensuring patient safety and market readiness.
Stepes operates under an ISO 13485-certified quality management system that is purpose-built for medical devices. This standard provides a framework for consistent translation workflows that meet global regulatory requirements. Every project includes documented procedures, version control, and audit-ready records to support FDA, EU MDR, and international submissions. By applying ISO 13485 principles, Stepes ensures that translated labeling is accurate, complete, and fully compliant with industry expectations.
In addition to ISO 13485, Stepes adheres to ISO 17100 for translation quality and ISO 9001 for overall process management. This combination strengthens consistency, terminology accuracy, and process reliability across large volumes of labeling content. Linguists are carefully qualified according to ISO 17100 requirements, and all workflows are continuously monitored and improved through ISO 9001 practices. These integrated standards create a robust system that guarantees precision and reliability in every translation.
Stepes incorporates full traceability and validation into its translation process. Each step, from linguist assignment to final delivery, is logged and verifiable, ensuring accountability at every stage. Risk management measures are built into the workflow, including terminology checks, regulatory reference validation, and automated QA tools that flag inconsistencies. These safeguards reduce the likelihood of errors in IFUs, packaging, and e-labeling, helping device manufacturers minimize compliance risks and maintain patient safety.
Types of Medical Device Labeling Content We Translate
Stepes provides end-to-end translation support for all forms of medical device labeling. Our specialized linguists and ISO 13485-certified workflows ensure accuracy, compliance, and readability across every document type.
- Instructions for Use (IFUs): Comprehensive translation of device instructions to ensure patients and healthcare professionals can safely and correctly operate the product in their local language.
- Packaging labels and inserts: Translation of carton labels, blister packs, and package inserts with precise formatting to meet FDA, EU MDR, and international packaging regulations.
- Electronic labeling (e-labels): Support for digital IFUs and QR code-based e-labeling in compliance with global adoption of electronic documentation standards.
- Safety and compliance warnings: Translation of mandatory safety statements, hazard information, and compliance symbols following ISO 15223-1 and IEC 60601 standards.
- Quick reference guides and manuals: Clear and concise multilingual guides that provide rapid user instructions without compromising accuracy or compliance.
- Device software UIs and embedded labels: Localization of on-device software interfaces, menu labels, and embedded text to ensure seamless usability across languages.
- UDI (Unique Device Identifier) documentation: Translation and formatting of UDI data elements to align with GS1, HIBCC, and ICCBBA standards for global market compliance.
- Marketing and promotional labeling: Translation of claims, product descriptions, and promotional labeling to align with regulatory requirements while maintaining brand integrity.
Global Regulatory Compliance in Labeling Translations
Accurate labeling translation is central to meeting international regulatory requirements. Stepes helps medical device manufacturers comply with multilingual labeling standards worldwide by aligning every project with the specific rules of each market.
The European Union requires medical device labeling to be translated into the official languages of each member state. Stepes delivers compliant translations for IFUs, packaging, and e-labels that meet MDR rules on safety, readability, and patient accessibility.
In the United States, the FDA mandates that device labeling provide clear and accurate instructions to protect patients and healthcare providers. Stepes ensures translations follow FDA requirements for general medical devices under Part 801 and in vitro diagnostics under Part 809.
Each market enforces strict labeling rules covering translation accuracy, terminology, and formatting. Stepes provides country-specific expertise to meet NMPA guidance in China, PMDA submission needs in Japan, ANVISA regulations in Brazil, and COFEPRIS standards in Mexico.
EU MDR requires ongoing monitoring and updates to labeling based on post-market surveillance data. Stepes supports manufacturers by translating revised IFUs, safety notices, and updated warnings quickly and accurately to maintain compliance across all languages.
Evolving Trends in Medical Device Labeling
Medical device labeling is changing rapidly as regulators and manufacturers adopt new technologies and patient-focused approaches. Stepes helps clients stay ahead of these trends by delivering translation solutions that meet emerging requirements.
Regulators in the EU and other regions now accept electronic instructions for use as a replacement or supplement to printed materials. Stepes provides translation workflows for digital IFUs, QR code–based access, and mobile-enabled labeling formats that reduce costs and improve accessibility.
Unique Device Identifier systems are being adopted worldwide to improve device traceability and patient safety. Stepes translates and validates UDI data elements according to GS1, HIBCC, and ICCBBA standards, ensuring consistent compliance across markets in North America, Europe, and Asia.
Regulators are requiring labeling that can be easily understood by patients as well as healthcare professionals. Stepes delivers translations that emphasize clarity, cultural appropriateness, and readability while meeting the technical standards of EU MDR and FDA guidelines.
The EU MDR mandates continuous monitoring of device safety, which often leads to labeling revisions. Stepes provides rapid translation and version control for updated IFUs, warnings, and safety communications to keep products compliant and market-ready.
Advanced Labeling Translation Solutions
Stepes combines proven linguistic expertise with modern tools to deliver accurate, compliant, and efficient medical device labeling translations. Our processes are designed to handle the technical complexity of regulated labeling while ensuring consistency and global readiness.
Centralized linguistic assets improve accuracy, accelerate turnaround, and ensure consistent use of approved medical terminology across IFUs, packaging, and e-labels.
Stepes performs translations directly within layouts and labeling systems to detect truncation, spacing, and formatting issues before release. This prevents costly rework and improves usability.
Our workflows accommodate all major authoring and publishing environments, enabling seamless integration into content management and labeling production pipelines.
Stepes connects with enterprise LMS platforms to streamline labeling updates, synchronize translations, and maintain version control across markets.
Advanced automation speeds up initial translation while professional linguists perform validation and editing to ensure regulatory accuracy and patient safety.
Built-in validation tools verify compliance with standards such as ISO 15223-1 and IEC 60601, ensuring consistent use of safety symbols, character limits, and document structure.
Multilingual Compliance for Global Markets
Successful medical device labeling requires accurate translation across multiple languages and regions. Stepes delivers multilingual compliance solutions that enable manufacturers to meet global regulatory requirements while accelerating time to market.
Stepes provides specialized medical device translations in more than 100 languages, ensuring that labeling meets local regulatory requirements across North America, Europe, Asia, and Latin America.
Consistency in terminology is critical for global submissions. Stepes applies centralized glossaries and translation memory to harmonize technical terms and regulatory language across regional markets.
Every translation project includes version control, quality records, and compliance documentation that can be presented during audits or inspections by regulatory authorities and notified bodies.
Stepes manages complex multilingual projects to deliver IFUs, packaging, and e-labels across multiple regions at the same time. This approach supports synchronized product launches and ensures consistency across global markets.
Life Sciences Expertise for Medical Device Translations
Medical device labeling requires more than language proficiency. It demands subject matter expertise, regulatory knowledge, and experience with complex device documentation. Stepes provides specialized linguists and project teams dedicated to the life sciences sector, ensuring every translation meets the highest standards of accuracy and compliance.
Stepes assigns translators with proven experience in medical device labeling, covering low-risk Class I products through high-risk Class III devices. Each linguist is trained to handle technical terminology, safety-critical language, and regulatory requirements.
Our teams are familiar with terminology governed by international standards and regional regulations, including ISO 15223-1 symbols, FDA labeling requirements, and EU MDR terminology guidelines. Consistent use of approved terms ensures accuracy and reduces the risk of compliance issues.
Stepes has supported labeling projects that range from traditional IFUs and packaging inserts to modern requirements such as Unique Device Identifier documentation and embedded software labeling. This experience allows us to deliver reliable translations for both physical and digital formats.
Quality Assurance & Risk Management
Quality assurance is central to Stepes’ approach to medical device labeling translation. Every project follows a multistage TEP workflow that includes translation, editing, and proofreading by qualified linguists with device expertise. This layered process ensures accuracy, consistency, and regulatory compliance across all labeling materials. To further strengthen quality, Stepes incorporates in-country review to validate translations against local regulatory and cultural requirements, providing additional assurance for submissions and audits.
All deliverables are produced with full traceability, version control, and change tracking to create an audit-ready record that meets the expectations of notified bodies and regulatory authorities. Stepes aligns every project with the requirements of EU MDR, FDA 21 CFR Part 801 and 809, and ISO standards such as ISO 13485, ISO 17100, and ISO 9001. This structured quality and risk management framework reduces the likelihood of labeling errors, safeguards patient safety, and supports faster approvals in international markets.
Proven Success in Medical Device Labeling Translation
Stepes has a proven record of supporting global medical device manufacturers with compliant, multilingual labeling solutions. One example includes the translation of IFUs and packaging materials for a Class III cardiovascular device into more than twenty languages, enabling successful market entry across Europe, Asia, and Latin America. Another project involved XML-based translation workflows that supported e-labeling compliance under the EU MDR, ensuring accurate integration into digital labeling systems without disrupting regulatory timelines.
Our experience extends to large-scale product launches where consistent translation quality has contributed to smooth regulatory audits and approvals. By combining ISO 13485-certified processes, subject matter expertise, and advanced technology, Stepes has become a trusted partner for companies that require accurate and audit-ready labeling across multiple jurisdictions. These successes demonstrate our ability to manage complex translation requirements while safeguarding patient safety and accelerating global market access.
Why Choose Stepes for Medical Device Labeling Translations
Stepes delivers medical device labeling translations backed by internationally recognized certifications and proven global expertise. Our ISO 13485 certification ensures that every project follows a medical device–specific quality management system designed to meet the stringent requirements of EU MDR, FDA, and other regulatory authorities. Combined with ISO 17100 translation quality standards and ISO 9001 process controls, our workflows provide the assurance that each translation is accurate, consistent, and fully audit-ready.
With support for more than 100 languages, Stepes enables manufacturers to launch devices seamlessly across all major markets. Our extensive network of professional linguists brings medical device subject matter expertise, regulatory knowledge, and native-language proficiency to every project, from IFUs and packaging to e-labeling and UDI documentation.
Stepes also offers around-the-clock project management with agile delivery models that meet tight deadlines and complex submission schedules. By combining advanced translation technology with human expertise, we help device companies reduce compliance risk, accelerate regulatory approval, and expand patient access to life-saving products worldwide.
Frequently Asked Questions – Chinese Patent Translation Services
ISO 13485 is the international quality management standard for medical devices. It defines processes that ensure safety, consistency, and regulatory compliance across all device-related documentation. For labeling translations, ISO 13485 certification demonstrates that Stepes follows controlled workflows with traceability, risk management, and audit-ready documentation. This provides manufacturers with confidence that multilingual labeling will meet the expectations of regulators worldwide.
EU MDR (2017/745) requires that device labeling, IFUs, packaging inserts, safety notices, and e-labeling be translated into the official languages of every EU member state where the product is marketed. Translations must be accurate, complete, and clear enough to be understood by patients and healthcare professionals. Stepes provides compliant multilingual translations that align with these requirements and help ensure successful market approvals in Europe.
Stepes follows ISO 13485-certified processes combined with ISO 17100 translation quality standards to meet the labeling regulations of both the FDA and EU authorities. Our workflows include multistage review, in-country validation, and automated QA checks to confirm compliance with FDA 21 CFR Part 801 and 809 as well as EU MDR requirements. This approach reduces compliance risks and supports smooth regulatory audits.
Yes. Stepes has extensive experience translating IFUs and Unique Device Identifier documentation for Class I, II, and III devices. Our linguists are trained in device-specific terminology, and our workflows validate UDI data against GS1, HIBCC, and ICCBBA standards. This ensures accuracy and compliance for both high-volume Class I submissions and complex Class III devices.
Stepes uses in-context translation tools and cosmetic testing to ensure that translated text fits within strict space and character limits. Our process includes automated checks for text expansion, symbol usage, and layout integrity. This prevents truncation and formatting issues while maintaining compliance with labeling standards.
Yes. Stepes translates content for traditional printed IFUs, labels, and inserts as well as digital formats such as XML-based e-labels, QR code instructions, and online IFUs. Our workflows are designed to integrate with content management and labeling management systems, allowing manufacturers to meet both traditional and digital labeling requirements.
Unlike general translation agencies, Stepes specializes in life sciences and medical devices. We combine ISO 13485 certification, domain-specific linguists, and advanced translation technology to deliver audit-ready, compliant labeling translations in more than 100 languages. Our global network, 24/7 project management, and proven track record in regulatory submissions make Stepes a trusted partner for device manufacturers seeking accuracy, compliance, and speed.
Safeguard Patient Safety with ISO 13485-Compliant Labeling Translations
Ensure global compliance and accelerate market approvals with Stepes’ specialized medical device labeling translation services. Our certified workflows, expert linguists, and worldwide coverage provide the accuracy and reliability needed for regulatory success.
