01
Assay, Reagent & Instrument
Establish consistent terminology for assays, analytes, biomarkers, specimens, reagents, calibrators, controls, instruments, and diagnostic workflows.
ISO 17100 Certified
ISO 13485 Certified
ISO 9001:2015 Certified
150+ Languages
Life Sciences Specialists
Translate the Diagnostic System, Not Just Individual Documents
An in vitro diagnostic product is a connected system in which the same scientific, technical, performance, and safety concepts can appear across assays, instruments, performance evidence, technical documentation, IFUs, labels, and software.
Sesen helps diagnostics teams maintain terminology continuity and controlled multilingual content across those touchpoints—reducing terminology drift, simplifying reviewer alignment, and supporting consistent product updates across markets and versions.
Assay / Reagent
Performance Evidence
Technical Documentation
IFU
Labeling
Software
IVDR / Release
Post-Market
Terminology governance and approved language span every touchpoint.
One diagnostic system. One controlled multilingual content ecosystem.
Multilingual Support Across the IVD Product Lifecycle
Sesen supports multilingual IVD content from product development and performance evaluation through regulatory review, market release, and post-market change.
02
Technical Documentation
Translate device descriptions, intended purpose, risk documentation, verification and validation records, manufacturing information, and other controlled technical content.
03
Performance Evaluation & Clinical Evidence
Support scientific validity, analytical performance, clinical performance, performance studies, and related evidence with specialized scientific translation.
04
Instructions for Use
Maintain clear multilingual instructions across specimen handling, assay procedures, instrument operation, performance characteristics, interpretation, limitations, and warnings.
05
Labeling & Packaging
Align kit labels, reagent labels, instrument labels, packaging, warnings, storage information, identifiers, and market-specific product language.
06
Software & Digital Interfaces
Localize analyzer interfaces, diagnostic applications, result screens, dashboards, alerts, operator prompts, help content, and connected diagnostic experiences.
07
IVDR Submission & Market Release
Support IVDR technical documentation, performance-related content, SSPs where applicable, regulatory communication, IFUs, labeling, and multilingual release packages.
08
PMS, PMPF & Lifecycle Updates
Maintain multilingual continuity as post-market evidence, product changes, software releases, IFU updates, and labeling changes move through the lifecycle.
Precision Starts with the Diagnostic Product
IVD terminology sits at the intersection of laboratory science, clinical interpretation, device performance, and regulated product use. Sesen supports diagnostic content with professional life sciences linguists and reviewers matched to the subject matter, language, document type, and intended audience.
Analytes and biomarkers
Qualitative and quantitative testing
Reference intervals and decision limits
Analytical and clinical sensitivity
Measuring ranges and detection limits
Interference and cross-reactivity
Result interpretation
IVD Technical Documentation for Global Regulatory Programs
Sesen helps diagnostics manufacturers translate controlled technical content while maintaining terminology and document relationships across multilingual regulatory programs.
Device descriptions and specifications
Intended purpose and intended-use content
Design and manufacturing information
Risk management documentation
General Safety and Performance Requirements (GSPR) documentation
Verification and validation reports
Technical reports and specifications
Declarations and supporting records
Change-control and post-market technical documentation
Keep Technical Evidence Connected to Product Language
Device descriptions, intended purpose, performance claims, warnings, limitations, and other key concepts can also appear in IFUs, labels, software interfaces, performance documentation, and post-market materials.
Sesen helps maintain those relationships through centralized terminology, translation memory, reference management, and cross-document quality checks. For EU programs, workflows can support technical documentation associated with IVDR Annex II and Annex III content.
Performance Evaluation
Translate the Evidence Behind Diagnostic Performance
Performance evaluation is one of the areas that most clearly differentiates IVD content from general medical device documentation. Under the EU IVDR framework, it is a continuous process that brings together scientific validity, analytical performance, and clinical performance.
Scientific Validity
Translate the scientific evidence connecting an analyte or marker with a clinical condition or physiological state.
- Scientific validity reports
- Literature reviews and evidence summaries
- Analyte and biomarker documentation
- Supporting scientific references
Analytical Performance
Preserve the precise language, numbers, units, statistics, and test-method terminology used to demonstrate analytical performance.
- Sensitivity, specificity, accuracy and precision
- Repeatability and reproducibility
- Detection and quantitation limits
- Interference, cross-reactivity and measuring range
- Specimen handling, stability and metrological traceability
Clinical Performance
Support clinical performance studies and evidence that connect diagnostic results with defined clinical conditions, populations, or processes.
- Clinical performance study plans and protocols
- Clinical performance reports
- Clinical sensitivity and specificity
- Predictive-value documentation
- Statistical analyses and evidence summaries
Sesen also supports Performance Evaluation Plans and Performance Evaluation Reports. The performance evaluation report forms part of the technical documentation and is updated as clinical evidence evolves through the device lifecycle, making terminology continuity especially important across evidence, IFUs, labeling, software, and post-market content.
From Evidence to the Product Experience
The scientific and regulatory language behind an IVD ultimately reaches users through instructions, labels, instruments, and software. Sesen helps keep those touchpoints synchronized.
Instructions for Use
IVD IFUs That Preserve Technical Meaning
Translate scientific information, laboratory procedures, instrument operation, performance characteristics, result interpretation, limitations, warnings, storage, and troubleshooting within one controlled user document.
- Specimen requirements and handling
- Assay procedures and instrument operation
- Performance characteristics and result interpretation
- Limitations, warnings and troubleshooting
Labeling & Packaging
Keep Labels, Packaging and IFUs Aligned
Maintain terminology across space-constrained labeling while preserving consistency with approved IFUs, technical documentation, and product information.
- Kit, reagent, calibrator and control labels
- Storage, handling and warning language
- Symbols and accompanying text
- Market-specific label and packaging variants
Software & Digital Interfaces
Localize the Software Behind Modern Diagnostics
Connect analyzer interfaces, embedded software, result screens, alerts, operator prompts, dashboards, help content, and connected diagnostic applications to the same approved product terminology.
- Analyzer and instrument UI
- Result screens, dashboards and reporting
- Alerts, errors and operator prompts
- Context review, screenshots and in-context QA
IVDR Translation Support from Conformity Assessment to Market Release
Sesen supports manufacturers managing multilingual content across IVDR technical documentation, performance evaluation, notified body interaction, IFUs, labeling, market release, and ongoing product maintenance.
Technical documentation
Performance evaluation
Scientific validity documentation
Analytical performance
Clinical performance
Performance study materials
IFUs and labeling
Regulatory questions and responses
Market-specific product information
Post-market documentation
One Terminology System Across Every Diagnostic Touchpoint
A single diagnostic concept can move through scientific evidence, technical documentation, IFUs, labels, software, and post-market content. Shared terminology helps preserve the right meaning in every context.
Intended Purpose
Technical documentation
Performance evidence
SSP
IFU
Labeling
Analytes & Biomarkers
Scientific validity
Performance documentation
IFU
Software
Results
Assay Procedures
Validation
Instrument workflows
IFU
Training
Updates
Warnings & Limitations
Risk documentation
IFU
Labeling
Software
Post-market
Performance & Results
Performance evaluation
Reference information
IFU
Result interface
User documentation
Manage Multilingual Change After Market Release
IVD translation does not end at launch. New post-market information, updated performance evidence, revised labeling, software changes, regulatory requirements, and new markets can affect multiple product assets at once.
PMS plans and reports
PMPF plans and reports
PSURs where applicable
Vigilance-related content
Performance updates
Revised IFUs and labeling
Software releases
Product change documentation
Evidence
Market Release
Post-Market Information
Product Update
New Multilingual Release
Translation memory, delta workflows, terminology continuity, reviewer feedback, and centralized release coordination help preserve approved language while focusing effort on changed content.
Translation Expertise Across Diagnostic Technologies
Sesen supports IVD manufacturers across a broad range of diagnostic technologies, laboratory environments, users, and software-enabled product systems.
Molecular Diagnostics
Molecular assays, nucleic-acid testing, PCR-related content, genomic workflows, instruments, software, performance documentation, IFUs, and labeling.
Immunodiagnostics
Immunoassays, serology, immunochemistry, reagents, instruments, performance documentation, and associated user instructions.
Clinical Chemistry
Chemistry analyzers, reagents, calibrators, controls, assay documentation, software, technical materials, and laboratory workflows.
Hematology & Coagulation
Diagnostic systems, analyzers, reagents, procedures, performance documentation, operating content, and user-facing materials.
Microbiology & Infectious Disease
Assays, testing systems, laboratory documentation, performance information, IFUs, labeling, software, and regulatory content.
Companion Diagnostics
Technical documentation, performance evidence, labeling, IFUs, and related content associated with corresponding medicinal products.
Point-of-Care & Near-Patient Testing
Clear multilingual operating instructions, user guidance, software, labels, and result information for testing closer to the patient.
Self-Testing IVDs
Lay-user IFUs, labels, digital interfaces, warnings, procedures, and result interpretation designed for intended-user comprehension.
Laboratory Instruments & Automation
Analyzer documentation, instrument software, automation workflows, operating instructions, maintenance, troubleshooting, and supporting content.
Scale IVD Content Across Global Markets
Sesen provides centralized multilingual support across 150+ languages to help diagnostics teams coordinate regulatory, labeling, software, IFU, and product content across international launches and recurring updates.
European MarketsIVDR-related content and market-specific language programs across EU and EEA markets.
North AmericaMultilingual documentation, labeling, scientific content, software, and regional market needs across the United States and Canada.
Asia-PacificJapanese, Simplified and Traditional Chinese, Korean, and other Asia-Pacific language programs for diagnostic products.
Global ProgramsCentralized delivery across 150+ languages, including complex scripts, right-to-left languages, multilingual formatting, and reviewer coordination.
Specialized Human Expertise, Supported by Controlled Technology
IVD content can combine scientific evidence, technical procedures, regulatory language, software, numerical data, and safety information. Sesen combines professional human expertise with controlled language technologies to support accuracy, consistency, scalability, and quality visibility.
For suitable, client-approved use cases, SesenGPT or other controlled AI-assisted workflows may support draft translation, terminology work, content reuse, or quality validation. Professional life sciences linguists and reviewers remain central to regulated diagnostic workflows, and automated QA findings are surfaced for human evaluation rather than treated as regulatory decisions.
Professional IVD & Life Sciences Linguists
Specialists are selected according to language, subject matter, document type, intended audience, and project requirements.
Terminology & Translation Memory
Approved terminology, product references, prior translations, and reviewer feedback provide a controlled foundation for recurring IVD content.
Independent Human Review
Structured bilingual review and final human quality control remain central to regulated diagnostic workflows.
AI-Assisted Quality Validation
AI-enabled and programmable QA can surface terminology, number, unit, omission, consistency, formatting, and placeholder issues for human evaluation.
ISO 17100Translation processes
ISO 13485Medical device quality processes
ISO 9001:2015Quality management
Secure WorkflowsControlled content handling
Why IVD Teams Choose Sesen
IVD & Life Sciences Specialization
Workflows are designed around regulated diagnostic, medical device, scientific, and life sciences content rather than general technical translation.
Connected Content Management
Shared terminology, translation memory, references, and review decisions help keep evidence, IFUs, labels, software, and updates aligned.
Professional Human Review
Qualified linguists and reviewers remain central to meaning, terminology, context, readability, and final linguistic quality.
Scalable Global Delivery
Centralized project management supports individual documents, recurring releases, product portfolios, and coordinated programs across 150+ languages.
IVD Translation Services FAQs
Answers to common questions about IVD translation, IVDR documentation, performance evidence, software localization, terminology, and post-market updates.
IVD translation services support the multilingual translation and localization of content associated with in vitro diagnostic medical devices, including assays, reagents, instruments, technical documentation, performance evaluation, IFUs, labels, packaging, software, regulatory materials, training content, post-market documentation, and product updates.
IVDs use diagnostic-specific scientific and laboratory terminology involving analytes, biomarkers, specimen types, reagents, calibrators, controls, analytical and clinical performance, reference intervals, cutoffs, interference, cross-reactivity, and result interpretation. Under the EU IVDR, performance evaluation specifically addresses scientific validity, analytical performance, and clinical performance.
Sesen supports technical documentation, Performance Evaluation Plans and Reports, scientific validity documentation, analytical and clinical performance reports, performance study materials, IFUs, labels and packaging, SSPs where applicable, instrument manuals, diagnostic software, regulatory correspondence, risk and quality documentation, PMS and PMPF materials, training content, and recurring product updates.
Yes. Sesen supports translation and localization of technical documentation, performance documentation, IFUs, labeling, SSPs where applicable, regulatory communication, and post-market content used in IVDR programs. Language programs can be structured around applicable target markets, content types, languages, versions, and review requirements.
Under Article 29 of the EU IVDR, manufacturers of Class C and Class D devices must prepare a Summary of Safety and Performance, except for devices for performance studies. The SSP must be clear to the intended user and, where relevant, the patient. Sesen supports SSP translation and formatting while helping maintain terminology consistency with performance evaluation, technical documentation, IFUs, and related product content.
Yes. Sesen supports Performance Evaluation Plans and Reports, scientific validity documentation, analytical performance reports, clinical performance reports, performance study content, literature-related evidence, and supporting materials. Terminology and translation assets can be maintained as performance evidence is updated through the product lifecycle.
Yes. Sesen localizes analyzer and instrument interfaces, embedded software, workflow screens, operator prompts, alerts, result displays, dashboards, diagnostic applications, help content, and software documentation. Workflows can include context review, variables and placeholders, text-length constraints, screenshot review, linguistic testing, and recurring releases.
Sesen can establish shared terminology, translation memory, product references, style guidance, and review rules across related content. Version-aware workflows, reviewer feedback, and cross-document QA help approved language remain consistent as technical documentation, IFUs, labels, software, performance evidence, and post-market content evolve.
Support Global IVD Programs with Specialized Translation Expertise
From assays and performance evidence to IFUs, labels, software, IVDR documentation, and post-market updates, Sesen helps diagnostic manufacturers keep multilingual product content accurate, consistent, and controlled across the complete IVD lifecycle.