SaMD & Medical Device Software
Localization for Software as a Medical Device, device software functions, embedded interfaces, diagnostic and monitoring software, treatment-related software, and device companion applications.
Bring patient apps, clinician interfaces, medical software, connected devices, telehealth platforms, and other digital health products to global users with specialized life sciences localization.
Sesen combines professional medical linguists, terminology governance, localization engineering, in-context quality assurance, and structured multilingual workflows to help digital health teams deliver clear, consistent experiences across languages, devices, and markets.
Digital health increasingly connects patients, clinicians, software, medical devices, healthcare systems, and data through a single user experience. Every screen, instruction, alert, questionnaire, notification, and workflow can become part of that experience.
Sesen helps digital health organizations localize the language layer across these connected touchpoints so clinical meaning, user comprehension, product terminology, interface behavior, and release continuity work coherently across markets.
From standalone patient applications to regulated medical software and connected-care ecosystems, Sesen supports multilingual content across a broad range of healthcare technologies.
Localization for Software as a Medical Device, device software functions, embedded interfaces, diagnostic and monitoring software, treatment-related software, and device companion applications.
Create multilingual mobile experiences for patient onboarding, medication management, symptom tracking, appointments, health information, care guidance, reminders, notifications, and support.
Localize therapeutic software, treatment journeys, patient instructions, behavioral intervention content, adherence messaging, assessments, and progress information with consistent patient-facing terminology.
Support multilingual patient intake, registration, scheduling, consultation interfaces, messaging, questionnaires, care instructions, clinician workflows, follow-up, and help content.
Localize connected-device applications, wearables, device setup, measurement labels, monitoring dashboards, patient alerts, clinician notifications, and home-health experiences.
Support multilingual content across EHR/EMR-connected platforms, clinician dashboards, patient portals, clinical workflow software, eCOA/ePRO systems, and healthcare data interfaces.
The Language Layer
A digital health product is more than buttons and menus. The same application may contain patient instructions, clinical terminology, safety information, questionnaires, device messages, educational content, and support materials.
Sesen helps organizations manage these interconnected content layers through a unified multilingual workflow, keeping approved terminology and recurring language aligned as the product evolves.
Risk-Aware Localization
Not every string inside a digital health product carries the same clinical meaning or patient impact. Sesen can adapt translation, review, validation, and QA depth to the content's intended use, context, audience, risk, and applicable requirements.
Experience Content
Navigation, general interface labels, help content, settings, and nonclinical notifications.
Focus: UX · product terminology · context · efficient multilingual deliveryPatient-Facing Health Content
Patient instructions, health information, adherence messaging, treatment onboarding, and care guidance.
Focus: medical expertise · readability · terminology control · expert reviewClinical & Risk-Sensitive Content
Safety information, device prompts, treatment-related instructions, clinical assessments, and outcome instruments.
Focus: subject-matter expertise · controlled terminology · validation · rigorous in-context QAEnd-to-End Workflow
Effective digital health localization begins before the first string is translated and continues beyond translation itself. Sesen coordinates the linguistic, technical, contextual, and quality steps needed to move multilingual digital experiences toward release.
Start with the product, users, intended use, and the environments in which the content appears.
Prepare source files, screenshots, terminology, user roles, constraints, references, and existing language assets.
Apply qualified life sciences linguists, terminology management, translation memory, and appropriate localization technology.
Use formal validation where digital products include eCOA, ePRO, questionnaires, symptom scales, or other outcome instruments.
Review multilingual content inside screens and builds for context, truncation, variables, formatting, RTL behavior, and usability.
Maintain approved language assets, versions, terminology, updates, and multilingual release continuity as the product evolves.
Localization Engineering
Digital health localization operates at the intersection of language and software engineering. Sesen supports structured content and development workflows that help multilingual assets move efficiently through product release cycles.
Work with formats and resources such as JSON, XML, XLIFF, YAML, CSV, iOS strings, Android resources, resource bundles, and structured exports.
Preserve and validate variables, placeholders, tags, string identifiers, markup, character limits, formatting, and other nontranslatable elements.
Support localization workflows for iOS, Android, web applications, React Native, Flutter, and other structured software environments.
Keep pace with incremental releases through translation-memory reuse, terminology continuity, version-aware workflows, recurring QA, and multilingual release coordination.
Interoperable Health Environments
Modern healthcare experiences rarely exist inside a single application. Digital products may connect with EHRs, EMRs, clinical systems, patient portals, medical devices, and other healthcare platforms.
Sesen localizes the human-facing language layer within these environments—including interfaces, terminology, instructions, labels, messages, and patient- or clinician-facing content.
Sesen can manage multilingual content within environments using HL7 and FHIR (Fast Healthcare Interoperability Resources) while keeping the distinction clear: our role is language localization, not technical interoperability implementation or certification.
A translation may be linguistically correct in isolation and still fail inside the finished product. Digital-health quality therefore extends into validation, visual context, device behavior, accessibility, and the real user experience.
When digital products contain clinical outcome instruments, Sesen can support instrument-specific validation workflows, reconciliation, review, cognitive debriefing support where required, harmonization, documentation, and electronic-screen review.
Explore Linguistic ValidationReview localized mobile screens, desktop interfaces, device displays, screenshots, menus, alerts, forms, dynamic strings, and error states to identify issues that are difficult to see in isolated resource files.
Account for text expansion, RTL presentation, localized labels, screen-reader-facing language, navigation text, locale formatting, and other language considerations within digital experiences designed around current WCAG accessibility guidance.
Professional Expertise + Technology
Medical terminology, patient comprehension, software context, clinical meaning, interface constraints, and product risk all require judgment. Technology supports the workflow; qualified language professionals remain central to quality.
Professional linguists selected for relevant medical, clinical, technical, and life sciences expertise.
Manage approved product, medical, clinical, and brand terminology across screens, content, releases, and reviewer feedback.
Reuse previously approved language where appropriate to support consistency, efficient updates, and release continuity.
Use AI selectively for suitable drafting, terminology analysis, repetitive content processing, and quality checks—with expert review where medical meaning and product risk require it.
Security & Governance
Digital-health localization can involve sensitive healthcare, clinical, product, and patient-facing information. Sesen supports multilingual programs through controlled workflows designed for regulated and privacy-sensitive life sciences environments.
Sesen supports customers operating in environments shaped by healthcare privacy, medical-device, data-protection, and regional market requirements—including HIPAA- and GDPR-sensitive workflows and, where applicable, programs shaped by FDA medical-device/software expectations and EU MDR requirements. Localization helps address multilingual content needs within these environments; compliance of the finished product depends on the product, intended use, market, customer processes, and applicable requirements.
Quality, Compliance & SecurityStructured processes for receiving, managing, reviewing, and delivering customer content.
Project access managed according to workflow and customer requirements.
Maintain continuity across source revisions, translation updates, linguistic review, and multilingual releases.
Coordinate translation, terminology decisions, review, QA, and delivery through defined project processes.
Every digital health program brings together a different mix of users, content, technology, risk, and release requirements. These common program patterns show how Sesen can combine localization, validation, QA, and release support around the needs of the product.
PATIENT EXPERIENCE
A patient-facing application is expanding into multiple markets with onboarding, navigation, instructions, reminders, health information, and support content.
Professional localization · terminology governance · structured string processing · translation-memory reuse · in-context review · release coordination
RISK-SENSITIVE SOFTWARE
A software product combines standard UI content with treatment-related instructions, measurements, alerts, and other clinically significant language.
Content classification · life sciences linguists · controlled terminology · risk-sensitive review · technical string QA · interface review
DIGITAL CLINICAL OUTCOMES
A digital clinical platform needs multilingual patient-reported instruments presented accurately within electronic screens and workflows.
Instrument-specific linguistic validation · reconciliation · cognitive debriefing support where required · screen review · documentation
Global Delivery
A product designed for global patients and healthcare professionals must adapt to more than different words. Sesen supports digital health localization across 150+ languages with language- and locale-specific controls throughout the multilingual product experience.
Digital health localization often intersects with medical-device content, clinical software, patient-reported instruments, and broader healthcare communications.
Localization engineering, software strings, structured files, UI translation, software QA, and multilingual releases for clinical and medical applications.
Structured validation for COAs, eCOAs, ePRO instruments, patient questionnaires, symptom scales, and other clinical outcome measures.
Translation for medical-device software, IFUs, labeling, technical documentation, regulatory content, training, and post-market communications.
Language support for healthcare organizations managing multilingual medical, patient-facing, operational, and healthcare communications.
Learn how Sesen approaches eHealth, mHealth, SaMD, eCOA/ePRO, connected systems, in-context QA, continuous localization, RTL languages, and controlled AI-assisted workflows.
Talk With Team SesenDigital health localization adapts healthcare software, mobile applications, patient portals, clinician interfaces, connected-device experiences, and related content for users in different languages and markets. A complete program can include software-resource processing, terminology management, medical linguistic review, locale adaptation, in-context QA, accessibility considerations, linguistic validation where required, and ongoing multilingual release support.
eHealth is a broad category covering digital technologies used to support healthcare delivery and health information, while mHealth focuses more specifically on healthcare experiences delivered through smartphones, tablets, wearables, and other mobile technologies. Sesen supports both within a broader digital health localization framework.
Sesen supports patient mobile apps, SaMD, medical device software, digital therapeutics, telehealth platforms, patient portals, remote patient monitoring systems, connected devices and wearables, clinician platforms, EHR/EMR-connected applications, eCOA/ePRO systems, and clinical workflow software. The localization workflow is tailored to the product, content, users, intended use, and market requirements.
SaMD and other clinically significant medical software can contain language that affects treatment, diagnosis, monitoring, patient understanding, or safe product use. Some content may therefore require stronger subject-matter expertise, controlled terminology, deeper human review, additional QA, and more structured documentation than ordinary consumer application content.
Yes. Sesen provides specialized eCOA and ePRO translation and linguistic-validation support for clinical outcome assessments, patient-reported outcome instruments, questionnaires, symptom scales, diaries, and related digital clinical content. When formal validation is required, the workflow can extend beyond conventional UI localization into reconciliation, back translation, cognitive debriefing support, harmonization, documentation, and electronic-screen review as appropriate.
Sesen can provide linguistic and in-context QA using screenshots, localized builds, device screens, or other customer-provided product context. Review can identify truncation, incorrect context, layout issues, terminology inconsistencies, variables, date and number formatting, RTL presentation, navigation labels, alerts, and error messages. Technical product testing and software validation remain with the appropriate product or development teams unless specifically included in the agreed scope.
Sesen can support continuous and incremental localization through translation memory, terminology governance, structured software resources, version-aware workflows, recurring QA, and multilingual release coordination. Previously approved language can be reused where appropriate while new or changed content moves through the required translation and review workflow.
Yes. Localization for right-to-left languages can include linguistic translation plus in-context review of text direction, layout, navigation, interface components, numbers, mixed-direction strings, and screen presentation. Sesen can work with customer product and development teams to identify linguistic and visual issues within the localized experience.
Yes. Sesen can localize human-facing content within healthcare platforms and workflows that exchange information using standards such as HL7 and FHIR. This can include interfaces, labels, terminology, patient-facing information, clinician-facing language, messages, and related multilingual content. Sesen provides language localization rather than technical HL7/FHIR implementation or interoperability certification.
Sesen uses AI selectively within controlled multilingual workflows. Depending on the content and project requirements, AI can assist with translation drafting, terminology analysis, repetitive content processing, and quality checks. Professional linguists and subject-matter reviewers remain central where medical meaning, patient comprehension, clinical significance, or product risk requires human judgment.
From patient apps and SaMD to clinician platforms, connected devices, telehealth, eCOA, and digital therapeutics, Sesen helps life sciences organizations manage the language layer behind global digital health products.
Services
Submissions, SOPs, audits, and regulated documentation.
ICFs, protocols, site documents, and patient materials.
COAs, PROs, patient questionnaires, and clinical instruments.
Medical, scientific, and technical life sciences content.
AE reports, DSURs, safety updates, and drug surveillance.
Regulated labeling and packaging for global product markets.
Instructions for Use translation for medical devices.
Device labeling for safety, compliance, and market access.
In-layout linguistic QA for packaging, IFUs, and labels.
Formatting and layout support for multilingual submissions.
Human-reviewed AI translation for regulated content.
Checks for terminology, numbers, formatting, and quality.
AI-assisted terminology extraction and consistency.
Routing, validation, terminology control, and human review.
Machine translation post-editing by medical linguists.
Clinical, medical, software, and digital health platforms.
Digital health apps, portals, and patient tools.
Video, training, voiceover, subtitling, and audiovisual content.
Multilingual voiceover and subtitles for training and communications.
Commercial, brand, and campaign translation for global markets.
Clinical, regulatory, labeling, safety, and commercialization support.
Research, genomics, gene therapy, biosimilars, and emerging therapeutics.
IFUs, labeling, software, technical documentation, and compliance content.
Clinical study operations, recruitment, site communication, and trial documents.
Patient-facing content, EHR documentation, telehealth, and care communication.
Health authority, public health, policy, and compliance-driven communication.
Public health programs, policy documents, and global health initiatives.
Digital health platforms, patient portals, eCOA, and clinical software.
Study startup, patient materials, clinical documentation, and global trials.
Submissions, labeling updates, safety documents, and compliance workflows.
Scientific exchange, publications, training, and medical communications.
Labeling, packaging, launch materials, updates, and commercialization.
Review clinical, regulatory, labeling, or AI-enabled workflow needs.
Structured multilingual workflows for regulated life sciences operations.
Multilingual support for global submissions, labeling, audits, and SOPs.
Translations for ICFs, protocols, site documents, and patient recruitment.
Specialized translations for AE/SAE reports, DSURs, and safety updates.
In-layout linguistic QA for packaging, IFUs, and labeling compliance.
Structured multilingual workflows for labeling translation, validation, and approval.
Component-based translation for IDMP, SPL, and XML content workflows.
Global communication and multilingual engagement programs.
Comprehensive support for launching products in international markets.
Culturally adapted outreach and multilingual trial communications.
Consistent scientific and brand language across markets.
Localized training for internal teams, HCPs, and external stakeholders.
Translation of websites, portals, and mobile health apps.
Sesen combines expert linguists, validation-driven review, and AI-assisted technologies to support global life sciences operations.
Proprietary AI, terminology, validation, and workflow systems for regulated multilingual content.
AI-assisted translation workflows built for regulated life sciences content.
Human-reviewed AI translation for quality, consistency, and scalability.
Automated checks for terminology, numbers, formatting, and compliance.
AI-assisted term extraction, harmonization, and reuse across global content.
Structured workflows for multilingual labeling translation, review, and validation.
AI-enabled workflows for clinical, regulatory, safety, and digital health teams.
AI-assisted multilingual support for ICFs, protocols, and patient materials.
Structured AI workflows for submissions, labeling, and compliance content.
AI-enabled workflows for AE reports, DSURs, safety updates, and drug surveillance.
AI-assisted localization for portals, apps, eCOA, and digital health platforms.
Coordinated multilingual workflows with AI routing and human review.
Start with a pilot that combines SesenGPT, professional native medical linguists, terminology control, and validation-driven QA.
Expert perspectives on AI, regulatory content, and multilingual life sciences communication.
Trends, analysis, and expert perspectives on multilingual life sciences communication.
Guidance on AI-enabled workflows, validation, terminology, and compliance.
Best practices for clinical trials, submissions, labeling, and global content operations.
Proof points, learning resources, and practical tools for multilingual content programs.
Examples of multilingual workflow support across life sciences organizations.
On-demand sessions and expert discussions on regulated multilingual operations.
Terminology resources for consistency across multilingual content programs.
Decision-support content for AI governance, quality, compliance, and translation strategy.
Detailed guidance on AI workflows, translation strategy, and global compliance.
Answers to operational, regulatory, and localization workflow questions.
Browse educational, technical, and customer-facing resources from Sesen.
Explore guidance on validation, terminology, structured content, and multilingual operations for life sciences organizations.
Mission, leadership, and values that guide Sesen’s life sciences localization work.
Regional footprint, partner ecosystem, and company updates across the industry.
A focused partner for high-stakes multilingual life sciences operations.
Sesen combines life sciences specialization, multilingual operations, and AI-enabled workflows for organizations that need quality, consistency, and scale.
Discuss enterprise translation, localization, or AI-enabled workflow needs.
Choose the right path for a new translation, localization, or AI-enabled workflow.
Get pricing and turnaround estimates for regulated multilingual content.
Speak with our team about clinical, regulatory, labeling, or AI-enabled workflows.
Evaluate SesenGPT workflows for multilingual regulated content.
Connect with Sesen for enterprise programs, partnerships, and ongoing support.
Specialized support for global life sciences teams managing regulated multilingual content.
For general inquiries, support, and company information.
Life Sciences Translation Company
Sesen helps life sciences teams manage clinical, regulatory, labeling, and AI-enabled translation workflows across 150+ languages.
Trusted by life sciences teams for regulated multilingual content across clinical, regulatory, labeling, and healthcare workflows.
Services
Life Sciences Language Services
Explore Sesen services for clinical, regulatory, labeling, medical device, software, multimedia, and global commercial content.
Featured Services
ICFs, protocols, site documents, and patient-facing materials.
Submissions, SOPs, audits, and regulated documentation.
Labeling, packaging, and product content for global markets.
Instructions for use and medical device documentation.
More Services
COA, PRO, questionnaire, and instrument workflows.
Specialized translation for medical and scientific content.
Software, portals, apps, and connected health interfaces.
Video, voiceover, subtitles, and training content localization.
Remote and onsite interpreting for life sciences settings.
Commercial, launch, and market access content for global audiences.
Need Help Choosing?
Discuss clinical, regulatory, labeling, or AI-enabled translation needs with a life sciences specialist.
Life Sciences
Life Sciences
Explore Sesen support for pharmaceutical, biotechnology, medical device, CRO, healthcare, public health, and regulated content teams.
Core Life Sciences Sectors
Healthcare & Public Sector
Specialized Domain Expertise
Study startup, patient materials, clinical documentation, and global trials.
Submissions, labeling updates, safety documents, and compliance workflows.
Scientific exchange, publications, training, and medical communications.
Labeling, packaging, launch materials, updates, and commercialization.
Trust & Compliance
Plan a Global Program
Connect with Team Sesen to review clinical, regulatory, labeling, or AI-enabled multilingual workflow needs.
Explore structured multilingual workflows for clinical, regulatory, labeling, commercial, training, and patient engagement programs.
Global submissions, labeling audits, SOPs, and regulated documentation.
ICFs, protocols, site documents, patient materials, and recruitment content.
Structured workflows for labeling translation, validation, and approval.
In-layout linguistic QA for packaging, IFUs, labeling, and compliance.
AE and SAE reports, DSURs, safety updates, and surveillance content.
Component-based translation for IDMP, SPL, and XML content workflows.
Support for launching products across international markets.
Culturally adapted outreach and multilingual trial communications.
Consistent scientific and brand language across global markets.
Localized training for internal teams, HCPs, and external stakeholders.
Websites, portals, mobile health apps, and digital patient experiences.
Sesen combines expert linguists, validation-driven review, and AI-assisted technologies to support global life sciences operations.
EXPLORE SESENGPTConnect with Team Sesen to discuss clinical, regulatory, labeling, commercial, or AI-enabled multilingual operations.
AI & Innovation
AI
Powered by SesenGPT workflowsExplore Sesen AI workflows for translation, terminology, validation, labeling, clinical trials, regulatory content, safety, and digital health localization.
Core AI Platform
AI-assisted translation workflows built for regulated life sciences content.
Human-reviewed AI translation for quality, consistency, and scalability.
Automated checks for terminology, numbers, formatting, and compliance.
AI-assisted term extraction, harmonization, and reuse across global content.
Structured workflows for multilingual labeling translation, review, and validation.
Operational AI Solutions
AI-assisted multilingual support for ICFs, protocols, and patient materials.
Structured AI workflows for submissions, labeling, and compliance content.
AI-enabled workflows for AE reports, DSURs, safety updates, and drug surveillance.
AI-assisted localization for portals, apps, eCOA, and digital health platforms.
Coordinated multilingual workflows with AI routing and human review.
Controlled AI Translation Program
Start with a pilot that combines SesenGPT, professional native medical linguists, terminology control, and validation-driven QA.
EXPLORE SESENGPTDiscuss AI Workflows
Connect with Team Sesen to discuss AI-assisted translation, terminology governance, multilingual QA, and regulated life sciences workflows.
Resources
Resources
Explore all resourcesAccess expert perspectives, proof points, learning resources, and practical tools for multilingual life sciences content programs.
Industry Insights
Trends, analysis, and expert perspectives on multilingual life sciences communication.
Guidance on AI-enabled workflows, validation, terminology, and compliance.
Best practices for clinical trials, submissions, labeling, and global content operations.
Customer & Operational Resources
Examples of multilingual workflow support across life sciences organizations.
On-demand sessions and expert discussions on regulated multilingual operations.
Terminology resources for consistency across multilingual content programs.
Strategic & Technical Resources
AI Translation Guidance
Review insights on validation, terminology, structured content, compliance, and multilingual operations for life sciences organizations.
Explore AI InsightsResource Center
Explore Sesen resources for clinical, regulatory, AI-enabled, quality, and multilingual content operations.
Learn about Sesen's mission, leadership, values, global footprint, partners, and commitment to life sciences localization excellence.
Company Foundation
Global Presence
Why Teams Work With Sesen
Sesen combines life sciences specialization, multilingual operations, and AI-enabled workflows for organizations that need quality, consistency, and scale.
Talk With Team Sesen
Connect with Team Sesen to discuss enterprise translation, localization, or AI-enabled workflow needs.
Contact
Contact
Talk with our teamChoose the right path for a new translation, localization, AI-enabled workflow, partnership, or existing project support need.
Start a Project
Get pricing and turnaround estimates for regulated multilingual content.
Speak with our team about clinical, regulatory, labeling, or AI-enabled workflows.
Evaluate SesenGPT workflows for multilingual regulated content.
Enterprise Engagement
Why Organizations Contact Sesen
General Contact Information
For general inquiries, support, and company information, connect with Team Sesen and we will route your request to the right team.