Our IVD translations comply with FDA 21 CFR Part 809, EU IVDR 2017/746, ISO 13485:2016, ISO 15189:2022, ISO 18113 (IVD information supply), and CLIA regulations. All translations are produced under ISO 17100:2015 quality processes with full audit documentation.
Diagnostics & Laboratory
Diagnostics & LaboratoryTranslation Services
Day Translations provides expert translation services for in vitro diagnostic manufacturers, clinical laboratories, and point-of-care device companies — covering EU IVDR submissions, IVD labeling, assay validation documentation, and laboratory protocols in 500+ languages.
ISO 17100 CertifiedFDA · EU IVDR · ISO 13485IVD Specialists
ISO 27001 information security · HIPAA-aligned · GSA-approved vendor
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Our Services
Specialized translation for diagnostics & laboratory sciences.
Specialized translation for every document type in the in vitro diagnostics and laboratory sciences sector.
IVD Labeling
IVD Labels & Instructions for Use
Complete translation of IVD labeling, instructions for use, and package inserts meeting FDA 21 CFR Part 809, EU IVDR Annex I, and ISO 18113 requirements.
EU IVDR
EU IVDR Regulatory Submissions
Technical documentation, performance evaluation reports, and post-market performance follow-up (PMPF) plans for EU IVDR compliance and Notified Body review.
Validation
Assay Validation Documentation
Analytical validation reports covering accuracy, precision, linearity, specificity, and reference intervals — translated for FDA 510(k) and EU IVDR submissions.
Lab Protocols
Laboratory Protocols & SOPs
Standard operating procedures, quality control protocols, and laboratory method documentation translated for CAP, CLIA, ISO 15189, and accreditation purposes.
Clinical Perf
Clinical Performance Studies
Clinical performance study protocols, reports, and statistical analysis plans for IVD devices requiring clinical evidence for EU IVDR or FDA clearance.
Post-Market
Post-Market Performance Follow-Up
PMPF plans, periodic summary update reports (PSUR), and serious incident reports for EU IVDR post-market surveillance obligations.
Point-of-Care
Point-of-Care Device Materials
Translation of POC device labeling, rapid test instructions, and patient-facing materials for home-use IVD products in multiple languages.
ISO 13485
Quality Management Documentation
ISO 13485 quality management system documentation, design history files, and device master records translated for global regulatory submissions.
Regulatory Compliance
Built for global IVD regulatory requirements.
Every IVD translation is designed to meet the specific requirements of the target regulatory authority.
FDA 21 CFR Part 809
In Vitro Diagnostics
FDA regulations for in vitro diagnostic products, including labeling requirements, performance standards, and 510(k) premarket notification requirements for IVD devices.
EU IVDR 2017/746
EU In Vitro Diagnostic Regulation
EU In Vitro Diagnostic Regulation replacing IVDD, with significantly increased clinical performance requirements and new device classification rules for IVD manufacturers.
ISO 13485:2016
Medical Device QMS
International standard for quality management systems specific to medical devices and IVDs — required for CE marking and recognized by FDA, Health Canada, and TGA.
ISO 15189:2022
Medical Laboratory Accreditation
International standard for quality and competence in medical laboratories — applicable to clinical chemistry, hematology, microbiology, and molecular diagnostics labs.
CLIA Regulations
Clinical Laboratory Improvement
US Clinical Laboratory Improvement Amendments regulations governing laboratory testing quality, personnel standards, and proficiency testing for clinical laboratories.
ISO 18113
IVD Information Supply
International standard for information to be supplied by the manufacturer of in vitro diagnostic reagents and instruments — governing IVD labeling requirements globally.
Why Day Translations
The IVD & laboratory translation partner trusted globally.
The in vitro diagnostics industry operates at the intersection of analytical chemistry, molecular biology, clinical medicine, and regulatory affairs — and translation in this sector demands expertise across all four disciplines. Day Translations has assembled a dedicated IVD translation practice with linguists who hold advanced degrees in clinical chemistry, microbiology, molecular diagnostics, and medical laboratory science.
The EU In Vitro Diagnostic Regulation (EU IVDR 2017/746) has fundamentally transformed the European IVD market, imposing significantly higher clinical performance requirements and reclassifying the majority of IVD devices into higher risk classes. Day Translations provides IVDR-specialized translation teams who understand the specific requirements of Notified Bodies for performance evaluation reports, post-market performance follow-up plans, and the EU IVDR technical documentation structure.
For FDA submissions, our IVD translation specialists are familiar with the 510(k) pathway for moderate-risk IVDs, the PMA pathway for high-risk devices, and the De Novo classification process. We translate analytical validation reports covering the full range of performance characteristics — accuracy, precision, linearity, specificity, sensitivity, and reference intervals — with the technical precision required for FDA review under 21 CFR Part 809.
Clinical laboratory accreditation documentation represents another core area of our IVD practice. We translate ISO 15189 quality management documentation, CLIA compliance materials, CAP accreditation documents, and laboratory standard operating procedures for clinical chemistry, hematology, microbiology, immunology, and molecular diagnostics laboratories worldwide.
Key Capabilities
- EU IVDR technical documentation packages
- FDA 510(k) and PMA IVD submissions
- IVD labeling in 50+ languages (ISO 18113)
- Analytical validation report translation
- ISO 15189 laboratory accreditation documents
- CLIA and CAP compliance documentation
- Point-of-care device materials translation
- Clinical performance study report translation
Who We Serve
Serving the full diagnostics ecosystem.
IVD Manufacturers
Global manufacturers of in vitro diagnostic products requiring regulatory translation for FDA, EU IVDR, PMDA, and global market access.
- IVD labeling in 50+ languages
- EU IVDR technical documentation
- FDA 510(k) and PMA submissions
- Post-market performance follow-up
- ISO 13485 QMS documentation
Clinical Laboratories
Hospital laboratories, reference laboratories, and specialty testing facilities requiring translation for accreditation, compliance, and international operations.
- ISO 15189 accreditation documentation
- CLIA compliance materials
- Laboratory SOPs and protocols
- Proficiency testing documentation
- Quality management system manuals
Point-of-Care Companies
POC device manufacturers and rapid test developers requiring multi-language labeling and patient-facing instructions for global distribution.
- Rapid test instructions for use
- Home-use IVD patient materials
- POC device labeling (50+ languages)
- Clinical performance study reports
- Regulatory submissions for POC devices
Our Process
Six-step IVD translation process.
01
IVD Classification Review
IVD specialist reviews device class, submission pathway, and target regulatory markets to assign linguists with matching IVD expertise.
02
IVD Terminology Setup
Client-specific IVD terminology database established, including assay names, analyte designations, and regulatory terms per ISO 18113.
03
Expert Translation
Clinical chemist or molecular diagnostics specialist produces translation with full technical accuracy and regulatory compliance.
04
Independent Scientific Review
Second qualified IVD linguist independently reviews for technical accuracy, labeling clarity, and regulatory compliance.
05
DTP & Symbol Compliance
Desktop publishing team formats IVD labels and IFUs with correct ISO 7000/ISO 15223 symbols and multi-language layout.
06
Certified Delivery
Final documents delivered with Certificate of Translation, formatted files, and audit trail for regulatory submission.
FAQ
Frequently asked questions.
Yes. We provide comprehensive EU IVDR technical documentation translation, including performance evaluation reports (PER), post-market performance follow-up (PMPF) plans, risk management files (ISO 14971), and Declaration of Conformity. Our IVDR specialists understand the specific requirements of Notified Bodies and EUDAMED registration.
Yes. We specialize in multi-language IVD labeling packages, delivering translations in 50+ languages simultaneously using parallel translation teams. All labels are formatted to match the source layout with correct ISO 7000/ISO 15223 symbols and comply with the labeling requirements of each target market.
Analytical validation reports are translated by clinical chemists or laboratory scientists with direct experience in IVD validation. We translate all performance characteristics — accuracy, precision, linearity, specificity, sensitivity, reference intervals, and interference studies — with the technical precision required for FDA 510(k) and EU IVDR submissions.
Yes. We translate ISO 15189 quality management documentation for clinical laboratories seeking accreditation from national accreditation bodies. This includes quality manuals, SOPs, competency assessment records, and proficiency testing documentation. We also translate CAP accreditation materials and CLIA compliance documentation.
Standard IVD labeling translations are typically delivered within 3–7 business days depending on length and language pair. Expedited turnaround (1–2 business days) is available for urgent submissions. For multi-language packages (10+ languages), we deliver all languages simultaneously.
Yes. We translate POC device labeling, rapid test instructions, and patient-facing materials for home-use IVD products. These documents require both technical accuracy and plain-language accessibility. Our translators are trained in health literacy principles and follow FDA guidance for home-use IVD labeling.
We create and maintain client-specific Translation Memories and approved terminology glossaries for each IVD program. All translations leverage existing TM matches, and new terms are flagged for client approval. This ensures consistency across IVD labels, IFUs, validation reports, and regulatory submissions in the same package.
Ready to advance your diagnostics program?
Contact our IVD translation specialists. We respond within 15 minutes during business hours.
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