The Need for Clinical & Medical Software Localization
As healthcare and life sciences organizations expand globally, clinical and medical software applications must be accessible, intuitive, and compliant in every target market. From electronic health records (EHRs) and mobile health apps to clinical trial management systems (CTMS) and medical device interfaces, software is central to modern clinical workflows, patient engagement, and regulatory compliance.
Accurate and context-aware clinical software translation and medical software localization are critical—not only to enhance usability for healthcare professionals and patients but also to safeguard patient safety and ensure operational consistency across markets. Inaccurate or incomplete localization can result in miscommunication, clinical errors, and regulatory violations.
Localization of life sciences software must meet stringent international standards, aligning with the requirements of global regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Japan’s PMDA, and standards like ISO 13485 and IEC 62304. Localization errors are not just usability issues—they are compliance risks.
Sesen specializes in the technical and linguistic precision required for global software compliance, combining in-depth domain expertise with professional translation workflows to ensure that clinical and medical software performs accurately and safely—no matter the language or region.
Types of Software We Translate and Localize
Sesen provides expert clinical and medical software translation and localization services across a wide range of platforms used in life sciences. Our services support both patient-facing and clinician-facing systems, ensuring accurate linguistic adaptation, regulatory compliance, and a seamless user experience in every language.
We work with the following software types:
Clinical Trial Management Systems (CTMS)
Localization of investigator portals, study workflows, and reporting dashboards to support multilingual clinical trial operations.
Electronic Data Capture (EDC) Systems
Translation of eCRFs, audit trail messages, and subject-facing modules with attention to regulatory and data integrity standards.
Electronic Health Records (EHR) / Electronic Medical Records (EMR)
UI localization and terminology alignment to meet country-specific healthcare protocols and improve clinician efficiency.
Medical Imaging and Diagnostic Platforms
Language adaptation for visualization tools, image analysis interfaces, and reporting modules used in radiology and diagnostics.
Patient Portals and Mobile Health (mHealth) Apps
Localization of patient engagement tools, mobile UIs, consent forms, and notifications for global accessibility and health literacy.
Medical Device Interfaces and Embedded Software
Translation of on-screen instructions, control panel displays, and embedded UIs in line with ISO 13485 and IEC 62366 usability engineering standards.
Clinical Decision Support Systems (CDSS)
Localization of logic-driven alerts, recommendations, and clinical content to ensure safe, context-appropriate decision support across languages.
Pharmacovigilance Software
Translation of adverse event reporting interfaces, case tracking dashboards, and automated signal detection modules for multilingual safety monitoring.
Laboratory Information Management Systems (LIMS)
Localization of lab workflows, sample tracking interfaces, and compliance-related documentation for global laboratory operations.
Whether you’re developing custom clinical applications or localizing off-the-shelf platforms for international deployment, Sesen delivers precise, compliance-ready localization tailored to the complexities of regulated healthcare environments.
Our Specialized Services
Sesen delivers end-to-end clinical and medical software translation and localization services tailored to the rigorous demands of the life sciences industry. Our solutions are engineered to ensure linguistic accuracy, technical precision, and full compliance with global regulatory standards.
Medical Software Translation
Our medically trained linguists translate clinical and software content with domain-specific accuracy.
- Expert handling of complex medical terminology, procedures, and clinical trial protocols
- Use of validated term bases, client-specific glossaries, and life sciences style guides to ensure consistency
- Linguistic QA performed by native-speaking subject matter experts
User Interface (UI) Localization
We adapt software user interfaces for global markets without compromising usability or functionality.
- Support for multi-byte and right-to-left (RTL) character sets
- Layout adjustments for text expansion and UI constraints
- Context-aware string translation to preserve intent and clarity within constrained UI elements
Functional Testing & QA
We conduct in-language testing to verify that localized software behaves as intended across all target languages.
- UI verification, linguistic bug reporting, and display integrity testing
- Functional test cases for multilingual validation of workflows
- Optional user acceptance testing (UAT) with clinical end users
Regulatory Compliance Translation
Our translations align with global regulatory requirements to support audit-readiness and international submissions.
- Compliance with ISO 13485, IEC 62304, and local regulatory guidance (FDA, EMA, PMDA)
- Delivery of traceable, audit-ready language assets
- Support for validation and localization documentation
Help Documentation and eLearning Localization
We localize supporting materials to ensure consistent user understanding and training across regions.
- User manuals, quick-start guides, FAQs, and onboarding resources
- Multimedia tutorials, SOPs, and LMS-integrated eLearning content
- Terminology-aligned content to match localized software interfaces
Multilingual DTP and GUI Adaptation
We optimize visual and layout elements for translated content to ensure professional presentation and software usability.
- Desktop publishing (DTP) for multilingual documentation
- GUI adjustments to accommodate localized text and regional formatting norms
- Graphics, screenshots, and diagrams localized in sync with software content
Quality Assurance and Regulatory Alignment
At Sesen, quality and compliance are embedded into every stage of our clinical and medical software localization process. We operate under certified quality systems, including ISO 17100 for translation services, ISO 13485 for medical device localization, and ISO 9001 for quality management—ensuring consistent delivery of accurate, audit-ready language assets.
Our robust QA workflows include:
Bilingual Review and Linguistic QA
Our medically trained linguists translate clinical and software content with domain-specific accuracy.
- Expert handling of complex medical terminology, procedures, and clinical trial protocols
- Use of validated term bases, client-specific glossaries, and life sciences style guides to ensure consistency
- Linguistic QA performed by native-speaking subject matter experts
Subject Matter Expert (SME) Validation
We adapt software user interfaces for global markets without compromising usability or functionality.
- Support for multi-byte and right-to-left (RTL) character sets
- Layout adjustments for text expansion and UI constraints
- Context-aware string translation to preserve intent and clarity within constrained UI elements
Terminology Management and In-Market Review
We conduct in-language testing to verify that localized software behaves as intended across all target languages.
- UI verification, linguistic bug reporting, and display integrity testing
- Functional test cases for multilingual validation of workflows
- Optional user acceptance testing (UAT) with clinical end users
Regulatory and Data Privacy Compliance
Our translations align with global regulatory requirements to support audit-readiness and international submissions.
- Compliance with ISO 13485, IEC 62304, and local regulatory guidance (FDA, EMA, PMDA)
- Delivery of traceable, audit-ready language assets
- Support for validation and localization documentation
With Sesen, your localized software is not only linguistically accurate—it is also fully aligned with the technical, clinical, and regulatory standards essential to life sciences and healthcare.
Advanced Localization Technology with Human Oversight
At Sesen, we combine cutting-edge localization technology with expert human linguists to deliver high-quality, scalable clinical and medical software translation services. Our tech-enabled workflows are designed to increase consistency, reduce turnaround times, and support agile product development cycles—all while maintaining the accuracy and compliance required in life sciences.
Key Capabilities:
Computer-Assisted Translation (CAT) and Translation Management Systems (TMS)
We leverage leading CAT tools and cloud-based TMS platforms to manage complex multilingual projects, ensuring efficiency, transparency, and version control throughout the localization lifecycle.
Translation Memory (TM) and Terminology Management
Our system continuously builds and applies domain-specific Translation Memories and validated Term Bases to maintain consistency across releases, reduce costs, and accelerate future updates.
Client-Approved MTPE (Machine Translation Post-Editing)
For select content types, we offer MTPE using secure, domain-trained machine translation engines—only when explicitly approved by the client. All output is post-edited by experienced linguists to meet regulatory and clinical quality standards.
API-Based Localization Integration
We support API and connector-based workflows that integrate seamlessly into your development environment. This enables continuous localization, ideal for iterative releases and global software rollouts.
By integrating automation with linguistic and regulatory expertise, Sesen ensures that your software is localized accurately, efficiently, and ready for global clinical deployment.
Our Proven Process: From Source to Fully Localized Software
At Sesen, we follow a structured and quality-driven workflow to ensure your clinical and medical software localization is accurate, compliant, and ready for multilingual deployment. Our process is engineered for life sciences, balancing speed, precision, and regulatory alignment at every stage.
Discovery & Scoping
We begin with a detailed analysis of your software, content types, technical architecture, and compliance requirements. Our team defines the scope, supported languages, regulatory constraints, and integration needs to build a tailored localization strategy.
File Preparation and Engineering
Our localization engineers extract translatable content from UI strings, XML, JSON, RESX, and other structured files. We prepare language packs, handle encoding requirements, and ensure placeholders, variables, and markup are preserved for accurate translation.
Linguistic Translation & Localization
Medically trained linguists translate and localize content, adapting terminology, tone, and user flow for each market. We apply Translation Memory (TM), Term Bases (TB), and client-specific style guides to maintain consistency and reduce costs.
Functional and Linguistic QA
Our QA team performs in-language testing, validating both the functionality and linguistic quality of the localized software. This includes display verification, truncation checks, layout integrity, and context accuracy across all languages.
Client Review and Approval
Clients can review translated content and conduct optional in-country validation. Feedback is implemented through a structured change management process to align with clinical, technical, and brand expectations.
Final Delivery and Post-Deployment Support
We deliver finalized files in the required formats and assist with software reintegration. Our team remains available for post-launch support, including updates, hotfixes, and new language rollouts.
Why Sesen?
Sesen is a trusted partner for life sciences organizations seeking expert clinical and medical software localization services. Our team brings a deep understanding of both the technical and regulatory complexities involved in global software deployment for healthcare, pharmaceuticals, and medical devices.
100% Life Sciences Focus
Unlike generalist localization providers, Sesen is exclusively focused on the life sciences sector. Our processes, linguists, and technologies are purpose-built to support clinical, regulatory, and patient-facing applications in a highly regulated environment.
Dedicated Software Localization Engineers
We assign experienced localization engineers who specialize in life sciences software. From parsing file formats to managing continuous localization workflows, our engineers provide hands-on technical support throughout the product lifecycle.
Clinically Trained Linguists
Our linguists have backgrounds in medicine, pharmacology, or clinical research. This ensures that translations reflect the correct terminology, tone, and intent—especially for sensitive content involving patient data, diagnostics, or treatment guidance.
Proven Track Record
We’ve delivered successful localization projects for global pharmaceutical companies, medical device manufacturers, clinical research organizations (CROs), and health tech firms. Clients trust Sesen for projects requiring precision, speed, and regulatory alignment.
Fast Turnaround Without Compromising Quality
Our streamlined workflows and technology-enabled processes allow us to deliver high-quality translations on tight timelines. We support fast-track launches, updates, and multilingual rollouts without sacrificing linguistic or functional integrity.
Scalable Multilingual Support
Whether you’re localizing into five languages or fifty, Sesen offers scalable project management and linguistic resources to meet your needs. We support simultaneous multilingual delivery and ongoing content updates through centralized workflows.
Frequently Asked Questions (FAQs)
Do you support continuous localization workflows?
Yes. Sesen supports continuous localization through API-based integrations with your development environment, including CI/CD pipelines. This allows us to manage real-time updates, agile sprints, and rolling releases for multilingual clinical and medical software, ensuring consistency and speed across all localized versions.
Can you localize software into right-to-left (RTL) languages?
Absolutely. We localize software into RTL languages such as Arabic, Hebrew, and Urdu. Our team ensures correct text alignment, layout mirroring, UI adjustments, and proper font rendering—all essential for compliance, usability, and patient safety in RTL regions.
How do you handle in-country reviews?
Sesen offers flexible in-country review (ICR) workflows tailored to your internal teams or local affiliates. We provide bilingual review files, feedback tracking tools, and reviewer training where needed. All client feedback is validated by our linguists and incorporated into final language assets and term bases.
Do you provide linguistic validation for patient-reported outcome (PRO) tools?
Yes. We specialize in linguistic validation for PRO instruments, quality-of-life questionnaires, and clinical assessments. Our process includes forward and back translation, cognitive debriefing, and harmonization in accordance with ISPOR and regulatory guidelines to ensure conceptual equivalence and cultural relevance across languages.
Related Services
Sesen offers a full suite of specialized life sciences translation and localization services to support your global product lifecycle beyond software alone. Explore our related services to complement your clinical and medical software localization needs:
eHealth and mHealth Localization
Localization of mobile health applications, remote patient monitoring tools, and telehealth platforms—ensuring language accuracy, data privacy compliance, and intuitive user experience across global markets.
Drug Labeling & Packaging Translation
Precise translation of drug packaging, inserts, and labels in compliance with FDA, EMA, and local regulatory authorities. Supports safe and compliant distribution of pharmaceuticals worldwide.
IFU (Instructions for Use) Translation
Translation and formatting of IFUs for medical devices and diagnostics in alignment with MDR, IVDR, and ISO 20417. Includes multilingual DTP and regulatory formatting for submission-ready documents.
Life Sciences Software Engineering Support
Technical services to support global-ready software, including string extraction, i18n/l10n engineering, testing automation, and build integration. Ideal for clients developing or maintaining multilingual clinical platforms.
