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medical-device-software-localization

Precision-Driven Medical Device Software Localization

As medical technology evolves, software localization has become a critical component of global regulatory compliance and market expansion. Sesen provides ISO-certified medical device software localization that ensures accuracy, usability, and compliance with industry standards such as FDA, MDR, and ISO 13485.

Medical device software localization is the specialized process of adapting software interfaces, user instructions, and embedded content to ensure regulatory compliance and usability in target markets.

Unlike standard software translation, which focuses on converting text from one language to another, localization involves:

  • Linguistic Adaptation – Ensuring precise medical terminology and regulatory compliance.
  • Technical Integration – Adjusting software UI, data structures, and code frameworks.
  • User Experience Optimization – Enhancing accessibility for healthcare professionals and patients.

Modern MedTech localization extends beyond translation—it incorporates interface restructuring, regulatory adaptation, and multilingual usability testing to align with diverse healthcare environments.

Medical software must function seamlessly and accurately across different linguistic and regulatory environments. A misinterpreted command or inaccurate medical term can lead to compliance failures, usability issues, or even patient safety risks. Key reasons why medical device software localization is essential:

Regulatory Compliance Across Markets

  • United States – FDA (21 CFR Part 820, Part 11) requires software validation and strict documentation in approved languages.
  • European Union – MDR mandates accurate multilingual labeling and software localization.
  • Japan & Canada – PMDA and Health Canada impose language-specific requirements for software and user interfaces.

Enhanced Patient Safety & Risk Mitigation

  • Eliminates translation errors that could lead to misinterpretation of critical device functions.
  • Ensures medical professionals receive clear, region-specific instructions for device operation.

Optimized User Experience for Medical Professionals & Patients

  • Healthcare providers need intuitive, localized interfaces for effective device usage.
  • Patients require accurate localized guidance for medical apps and home-use devices.

 

Medical device software localization is essential for any organization developing healthcare-related software or hardware solutions, including:

  • Medical Device Manufacturers – Ensuring software interfaces comply with regional regulations.
  • Healthtech & MedTech Companies – Expanding global reach with multilingual software integration.
  • Hospitals & Clinical Research Organizations – Localizing electronic medical records, imaging systems, and decision-support software.

Sesen specializes in localization solutions tailored for high-risk medical applications, ensuring that every localized product meets stringent quality, compliance, and usability standards.

Regulatory Compliance & Industry Standards in Medical Device Software Localization

Global medical device software must adhere to strict regulatory frameworks to ensure patient safety, usability, and legal compliance across different markets. Sesen’s ISO-certified localization services align with international regulations, integrating linguistic accuracy, software validation, and risk mitigation into every project.

Each regulatory body enforces unique language and compliance standards for medical software. Non-compliance can result in market access delays, legal penalties, and product recalls.

U.S. FDA (21 CFR Part 820, Part 11)

  • Software validation for medical devices, ensuring accurate localization of electronic records and audit trails.
  • Labeling and user instructions must be available in languages appropriate for intended users.

European MDR & IVDR (Medical Device & In Vitro Diagnostic Regulation)

  • Mandatory multilingual support for all medical software distributed in the EU.
  • Strict requirements for localized eIFUs (electronic Instructions for Use) and safety labels.
  • Failure to provide accurate translations can invalidate CE marking and prevent market entry.

ISO 13485:2016 – Medical Device Quality Management

  • Defines global quality standards for medical device manufacturers.
  • Requires controlled translation processes to maintain documentation integrity across languages.
  • Localization workflows must be documented, traceable, and validated for audit readiness.

IEC 62304 – Medical Software Life Cycle Standards

  • Outlines risk-based software development processes, including localized software verification.
  • Localization teams must maintain version control and traceability for multilingual updates.

Health Canada & PMDA (Japan’s Pharmaceuticals and Medical Devices Agency)

  • Canada: Requires bilingual (English/French) software documentation and regulatory filings.
  • Japan: PMDA enforces strict linguistic validation for software used in clinical and hospital environments.

Risk Classification & Regulatory Labeling

  • Medical software falls under different risk classes based on potential harm to users (e.g., FDA Class I–III, MDR Class I–III).
  • High-risk devices (Class III) require full linguistic validation, usability testing, and compliance audits.
  • Localized regulatory labeling must align with UDI (Unique Device Identification) and GS1 standards.

Data Security & Patient Confidentiality

  • HIPAA (U.S.) & GDPR (EU) enforce strict data privacy laws for localized software handling patient records.
  • Medical software localization must ensure secure data encryption, anonymization of sensitive data, and compliance with cybersecurity best practices.
  • Any machine-translated content must be manually reviewed to prevent data leaks or misinterpretations.

Sesen’s regulatory-driven localization solutions help medical device companies navigate complex compliance landscapes, ensuring their products meet global standards without compromising accuracy, security, or usability.

Core Components of Medical Device Software Localization

Medical device software localization extends beyond simple translation—it requires technical precision, regulatory compliance, and seamless user experience integration. Sesen ensures that every component of medical software is linguistically and functionally adapted for global markets.

A medically accurate, user-friendly interface is critical for ensuring precision in diagnostics, treatment, and patient care.

  • Medical terminology consistency – Terminology aligned with SNOMED CT, ICD-10, and UMLS standards.
  • Localization of UI elements – Menus, buttons, error messages, tooltips, and pop-ups adapted for clarity and usability.
  • Character encoding & text expansion handling – Accommodating language-specific length variations (e.g., German vs. English).

Medical devices rely on embedded software that must function flawlessly across linguistic and regional settings.

  • Device interface localization – On-screen text, device settings, and real-time status notifications.
  • Multi-platform compatibility testing – Ensuring stable performance across different OS, hardware architectures, and display resolutions.
  • Regulatory-compliant terminology – Critical software labels (e.g., “Caution,” “Error,” “Start”) localized with precision.

eIFUs and manuals must be legally compliant, accurate, and accessible across all markets.

  • Clarity for different user groups – Medical professionals, technicians, and patients.
  • Multiformat support – PDF, in-app displays, and web-based repositories for easy access.
  • Structured terminology databases – Maintaining consistency between software labels and documentation.
  • Regulatory-mandated localization – Compliance with EU MDR eIFU guidelines for digital instructions.

As voice technology becomes integral to medical software, localization must account for linguistic and phonetic variations.

  • Multilingual voice control adaptation – Training models to recognize accents, dialects, and medical jargon.
  • Speech-to-text accuracy validation – Ensuring precise transcription of medical terms in different languages.
  • Compliance with pronunciation standards – Adapting AI-driven voice recognition for non-English-speaking medical professionals.

Medical software interacts with standardized data protocols that must be correctly localized and formatted.

  • DICOM & HL7 localization – Ensuring interoperability between international medical imaging and health record systems.
  • Consistent terminology across digital health records – Matching translated data fields with ICD-10, CPT, and LOINC standards.
  • UDI (Unique Device Identification) compliance – Localizing medical device tracking labels as per GS1 and FDA UDI requirements.

Sesen’s Best Practices for Medical Device Software Localization

Medical device software localization demands technical precision, linguistic accuracy, and regulatory compliance. Sesen follows industry-leading best practices to ensure that localized medical software functions flawlessly across global markets while meeting FDA, MDR, and ISO 13485 requirements.

Medical translation is high-risk—inaccurate terminology or ambiguous instructions can compromise patient safety and regulatory approval.

  • Industry expertise ensures precision – Sesen works exclusively with certified medical linguists who are experts in biomedical engineering, clinical research, and regulatory affairs.
  • SME-driven validation – Localization is reviewed by subject matter experts (SMEs) to ensure medical accuracy and compliance.
  • Terminology management – We maintain custom glossaries aligned with SNOMED CT, ICD-10, and MedDRA to ensure regulatory consistency.

Localized medical software must maintain integrity across languages, platforms, and regulatory frameworks.

  • Multi-step translation & review process – Incorporates translation, editing, proofreading (TEP), and back-translation for high-risk content.
  • Functional & linguistic testing – Ensures UI/UX elements, interactive workflows, and on-screen messages remain contextually accurate in all languages.
  • Regulatory compliance testing – Validation against FDA, MDR, Health Canada, and PMDA language regulations for software interfaces and electronic documentation.

To reduce costs and accelerate time to market, localization must be an integral part of the development cycle rather than an afterthought.

  • Agile & Continuous Localization (CL) – Localization teams work alongside developers to localize incremental software updates in real time.
  • Automated localization workflows – Integration with Git, CI/CD pipelines, and development repositories for seamless content deployment.
  • Developer-linguist collaboration – Direct integration between localization engineers and MedTech developers to resolve UI constraints, string dependencies, and hard-coded text issues.

While machine translation (MT) with post-editing (MTPE) can speed up localization, human expertise remains essential for regulatory compliance.

  • MTPE for efficiency – AI-driven translation can accelerate non-critical content localization, reducing turnaround time.
  • Human review for high-risk content – Software labels, error messages, and medical safety information require manual linguistic validation to eliminate misinterpretations.
  • Regulatory-driven accuracy – Automated translation tools cannot guarantee compliance with MDR, FDA, or ISO 13485 standards, making human expertise indispensable.

Why Sesen?

Sesen’s ISO-certified localization process ensures that medical device software meets global compliance standards while maintaining technical accuracy, linguistic precision, and optimal user experience.

Emerging Trends in Medical Device Software Localization

As healthcare technology evolves, Sesen stays at the forefront of medical device software localization, integrating AI-driven automation, mobile compatibility, wearable technology, and voice interfaces to meet the growing demands of global markets. With a focus on regulatory compliance, linguistic accuracy, and user-centric design, Sesen ensures that medical software is optimized for multilingual usability while adhering to international standards.

Artificial Intelligence (AI) and Neural Machine Translation (NMT) are transforming medical software localization by enhancing efficiency, consistency, and quality assurance.

  • Advanced NMT models – AI-driven translation engines provide context-aware medical translations while reducing turnaround time.
  • AI-powered quality control – Automated error detection, terminology validation, and linguistic consistency checks improve regulatory compliance.
  • Adaptive translation engines – Continuous learning from human-reviewed translations enhances accuracy for specialized medical terminology.

The global expansion of mHealth apps requires localization strategies that ensure regulatory compliance, accessibility, and seamless user experiences across diverse regions.

  • Multilingual UI/UX adaptation – Customizing navigation, alerts, and data inputs for international users.
  • Regulatory compliance for app stores – Apple App Store and Google Play impose strict localization guidelines for medical applications, including region-specific disclaimers and privacy policies.
  • Real-time localization support – Enabling in-app updates for dynamic content, telemedicine features, and patient monitoring tools.

Wearable medical technology—such as smartwatches, glucose monitors, and remote patient monitoring devices—is driving demand for real-time, multilingual localization.

  • On-device language adaptation – Ensuring medical alerts, vital signs, and instructional messages are accurately translated across multiple languages.
  • Data synchronization across languages – Interoperability with electronic health records (EHRs) and integration with HL7 and DICOM standards.
  • Regulatory compliance for digital health wearables – Localized privacy settings and data collection notices to comply with GDPR, HIPAA, and MDR requirements.

The integration of voice recognition and conversational AI in medical software demands linguistic precision and localization strategies tailored for different accents, dialects, and medical jargon.

  • AI-powered medical chatbots – Enhancing localized patient support, symptom tracking, and medication reminders.
  • Voice-based medical dictation – Adapting speech recognition models to capture medical terminology variations in different languages.
  • Compliance with multilingual voice interfaces – Ensuring accurate pronunciation recognition for clinical speech-to-text systems.

Sesen: Pioneering Medical Software Localization for the Future

By combining cutting-edge AI, regulatory expertise, and linguistic precision, Sesen delivers future-ready localization solutions for medical device software, ensuring compliance, usability, and multilingual accuracy in the rapidly evolving healthcare landscape.

Why Choose Sesen for Medical Device Software Localization?

Sesen is a trusted partner for medical device manufacturers and healthtech companies, providing ISO-certified localization services that ensure compliance, accuracy, and seamless user experiences across global markets. Our expertise in life sciences translation, regulatory requirements, and software engineering allows us to deliver high-quality localized solutions tailored for the medical industry.

  • Specialized Life Sciences & Medical Technology Expertise – Decades of experience localizing software for diagnostic tools, imaging systems, surgical robotics, and patient monitoring devices.
  • Proven Track Record with Leading MedTech Companies – Trusted by top medical device manufacturers to support global regulatory compliance and multilingual software deployment.
  • Regulatory Alignment & Risk Mitigation – Localization services that meet FDA, MDR, ISO 13485, and IEC 62304 requirements for software validation and compliance.

Sesen follows a structured, regulatory-compliant localization workflow designed to ensure accuracy, efficiency, and seamless integration into client development pipelines.

Step 1: Localization Strategy & Risk Assessment

  • Identify regulatory requirements per target market (FDA, MDR, PMDA, Health Canada).
  • Define terminology glossaries and translation memory for consistency.

Step 2: UI/UX & Software Content Translation

  • Linguistic adaptation of user interfaces, alerts, and on-screen messages.
  • Software string extraction and integration with agile development workflows.

Step 3: Compliance Review & Linguistic Validation

  • Multi-step quality assurance (QA), linguistic validation, and back-translation for high-risk content.
  • Functional testing to verify UI/UX consistency, text expansion, and multilingual rendering.

Step 4: Integration & Deployment

  • Localized software testing in real-world medical environments.
  • Support for continuous localization (CL) workflows to ensure ongoing software updates remain compliant.

Sesen leverages a hybrid localization model that combines AI-driven efficiency with expert human linguists to deliver high-quality medical translations.

  • ISO 13485-Certified Translation Processes – Ensuring strict quality control, regulatory compliance, and risk management.
  • AI-Assisted Workflow for Speed & Accuracy – Neural Machine Translation (NMT) with SME-driven post-editing for regulatory-sensitive content.
  • Cost-Effective & Scalable Solutions – Optimized localization workflows that reduce turnaround time without compromising quality.

Sesen has successfully localized medical software and device interfaces for leading global manufacturers, ensuring compliance, usability, and accuracy across multiple markets.

Case Study 1: Multilingual Localization for a Global Medical Imaging Platform

  • Challenge: Ensure linguistic accuracy and regulatory compliance across 20+ languages.
  • Solution: Implemented a customized translation memory & terminology management system.
  • Results: Reduced localization errors by 40%, improved global adoption, and accelerated regulatory approvals.

Case Study 2: Software Localization for an AI-Powered Surgical Robotics System

  • Challenge: Localize voice-enabled commands, user interfaces, and real-time patient monitoring data.
  • Solution: Deployed multilingual voice recognition models with SME-reviewed translations.
  • Results: Ensured full compliance with EU MDR and FDA regulations, improving usability for surgeons across 10+ regions.

Sesen’s expertise in medical device software localization ensures that our clients achieve seamless global market entry while maintaining the highest quality, accuracy, and compliance standards.

Get Started with Sesen’s Medical Device Software Localization Services

Take the next step toward global readiness with Sesen’s regulatory-compliant, ISO-certified localization solutions for medical device software. Whether you’re preparing for market entry or scaling internationally, we’re here to help.

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