We cover all FDA device classes (Class I, II, III) and submission pathways (510(k), PMA, De Novo, HDE), as well as EU MDR/IVDR Class I–III, PMDA Japan submissions, Health Canada Medical Device Licence applications, and TGA Australia submissions. We also support ANVISA (Brazil), NMPA (China), and other global regulatory markets.
Medical Devices
Medical DevicesTranslation Services
Day Translations provides regulatory-grade translation services for medical device manufacturers worldwide — covering 510(k), PMA, CE Mark, EU MDR submissions, IFU translation, UDI labeling, and post-market surveillance documentation in 500+ languages.
ISO 17100 Certified510(k) · PMA · CE MarkEU MDR / IVDR
ISO 27001 information security · HIPAA-aligned · GSA-approved vendor
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Documents Translated
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On-Time Delivery
Our Services
Specialized translation for medical devices.
Specialized translation for every document type in the medical devices sector.
IFU
Instructions for Use (IFU)
Complete IFU translation for Class I, II, and III medical devices — meeting FDA 21 CFR Part 801, EU MDR Annex I, and global labeling requirements. DTP formatting to match source layout.
510(k)/PMA
510(k) & PMA Submissions
Translation of 510(k) premarket notifications and PMA applications for FDA, including substantial equivalence arguments, performance testing data, and labeling.
CE Mark
CE Mark & EU MDR Documentation
Technical documentation, Declaration of Conformity, clinical evaluation reports (CER), and post-market clinical follow-up (PMCF) plans for EU MDR compliance.
UDI
UDI Labeling & Device Identification
Unique Device Identifier (UDI) labeling translation for FDA GUDID and EUDAMED databases, ensuring compliance with 21 CFR Part 830 and EU MDR Article 27.
CER
Clinical Evaluation Reports (CER)
Systematic literature reviews, clinical data analysis, and clinical evaluation reports translated for EU MDR Article 61 compliance and Notified Body review.
PMS
Post-Market Surveillance
PMCF plans and reports, Periodic Safety Update Reports (PSUR), and serious incident reports translated for EU MDR and FDA post-market requirements.
Software
Software as a Medical Device (SaMD)
IEC 62304 software lifecycle documentation, Software of Unknown Provenance (SOUP) lists, and AI/ML-based SaMD regulatory submissions.
Risk Mgmt
Risk Management Documentation
ISO 14971 risk management files, hazard analysis, risk control measures, and residual risk evaluation translated for global device submissions.
Regulatory Compliance
Built for global regulatory requirements.
Every translation is designed to meet the specific requirements of the target regulatory authority.
FDA 21 CFR Part 820
Quality System Regulation
FDA Quality System Regulation governing design controls, production, and process controls for medical devices — applicable to all 510(k) and PMA submissions.
EU MDR 2017/745
EU Medical Device Regulation
European Union Medical Device Regulation replacing MDD, requiring updated technical documentation, clinical evidence, and post-market surveillance for all CE-marked devices.
EU IVDR 2017/746
In Vitro Diagnostic Regulation
EU In Vitro Diagnostic Regulation replacing IVDD, with significantly increased clinical evidence 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 — required for CE marking and recognized by FDA, Health Canada, and TGA.
ISO 14971:2019
Risk Management
International standard for the application of risk management to medical devices — required for all CE Mark technical documentation and FDA submissions.
IEC 62304:2006
Software Lifecycle
International standard for medical device software lifecycle processes — applicable to SaMD, embedded device software, and AI/ML-based medical devices.
Why Day Translations
The medical devices translation partner trusted globally.
Medical device translation demands a unique combination of technical engineering knowledge, regulatory expertise, and linguistic precision. Instructions for Use (IFUs) must be translated with absolute clarity — a mistranslation can directly result in device misuse and patient harm. Clinical Evaluation Reports (CERs) must accurately convey the scientific evidence supporting a device's safety and performance. Day Translations has built a dedicated medical device translation practice with linguists who hold degrees in biomedical engineering, medical physics, clinical science, and regulatory affairs.
The EU Medical Device Regulation (EU MDR 2017/745) and EU In Vitro Diagnostic Regulation (EU IVDR 2017/746) have fundamentally transformed the European device market, imposing significantly higher clinical evidence requirements and more stringent post-market surveillance obligations. Day Translations provides MDR/IVDR-specialized translation teams who understand the specific requirements of Notified Bodies, including the detailed clinical evaluation report structure required under MDR Annex XIV and the MEDDEV 2.7/1 Rev 4 guidance.
For FDA submissions, our device translation specialists are familiar with the 510(k) substantial equivalence framework, the PMA approval pathway, and the De Novo classification process. We translate performance testing data, biocompatibility assessments (ISO 10993), sterilization validation reports, and electrical safety testing (IEC 60601) with the technical precision required for FDA review. Our teams also support PMDA submissions in Japan, Health Canada applications, and TGA applications in Australia.
Software as a Medical Device (SaMD) represents a rapidly growing area of our device translation practice. We translate IEC 62304 software lifecycle documentation, AI/ML transparency documentation, and Software of Unknown Provenance (SOUP) lists for digital health companies and medical device manufacturers incorporating software. Our translators understand the specific terminology of software engineering, cybersecurity, and AI/ML in the medical device context.
Key Capabilities
- IFU translation with DTP formatting to source layout
- EU MDR/IVDR technical documentation packages
- 510(k), PMA, and De Novo submission translation
- ISO 14971 risk management file translation
- IEC 62304 software lifecycle documentation
- UDI labeling for GUDID and EUDAMED
- Clinical evaluation report (CER) translation
- Post-market surveillance report translation
Who We Serve
Serving the full medical devices ecosystem.
Medical Device Manufacturers
Global manufacturers of Class I, II, and III medical devices requiring regulatory translation for FDA, CE Mark, PMDA, and global market access.
- 510(k) and PMA submission translation
- CE Mark technical documentation
- IFU translation in 50+ languages
- UDI labeling compliance
- Post-market surveillance reports
Notified Bodies & Regulatory Consultants
EU Notified Bodies and regulatory affairs consultants supporting device manufacturers through MDR/IVDR compliance and CE Mark certification.
- MDR/IVDR technical documentation review
- Clinical evaluation report translation
- PMCF plan and report translation
- Declaration of Conformity translation
- Notified Body audit documentation
Digital Health & SaMD Companies
Digital health companies and software developers seeking regulatory clearance for Software as a Medical Device (SaMD) and AI/ML-based medical devices.
- IEC 62304 software lifecycle documents
- AI/ML transparency documentation
- SaMD regulatory submissions (FDA/EMA)
- Cybersecurity documentation translation
- 510(k) for software-based devices
Our Process
Six-step medical devices translation process.
01
Device Classification Review
Regulatory specialist reviews device class, submission pathway, and target markets to assign device-specialized linguists.
02
Technical Glossary Setup
Device-specific terminology database established, including device trade names, technical specifications, and regulatory terms.
03
Expert Translation
Biomedical engineer or medical device specialist produces translation with full technical accuracy and regulatory compliance.
04
Technical Review
Second qualified device linguist independently reviews for technical accuracy, IFU clarity, and regulatory compliance.
05
DTP & Formatting
Desktop publishing team reformats IFUs, labels, and technical documents to match source layout and symbol standards (ISO 15223).
06
Certified Delivery
Final documents delivered with Certificate of Translation, formatted files, and audit trail for regulatory submission.
FAQ
Frequently asked questions.
Yes. Our desktop publishing team reformats translated IFUs to match the source document layout, including tables, diagrams, symbol usage (ISO 15223-1), and multi-language label formats. We deliver print-ready files in the original format (InDesign, Word, PDF) with all formatting preserved.
We provide comprehensive EU MDR/IVDR technical documentation translation, including clinical evaluation reports (CER/PER), post-market clinical follow-up (PMCF) plans and reports, risk management files (ISO 14971), and Declaration of Conformity. Our MDR/IVDR specialists understand the specific requirements of Notified Bodies and EUDAMED.
Yes. CER translation is a core service. Our translators understand the MEDDEV 2.7/1 Rev 4 structure and the MDR Annex XIV requirements for clinical evaluation. We translate systematic literature reviews, clinical data summaries, and benefit-risk analyses with the scientific precision required for Notified Body review.
Standard IFU translations are typically delivered within 5–10 business days depending on length and language pair. Expedited turnaround (2–3 business days) is available for urgent submissions. For multi-language IFU packages (10+ languages), we can deliver all languages simultaneously using parallel translation teams.
Yes. We translate UDI labeling for both FDA GUDID and EU EUDAMED databases, ensuring compliance with 21 CFR Part 830 and EU MDR Article 27. We can also assist with the translation of device identification information for submission to other global UDI databases.
All device translations are performed by linguists with biomedical engineering, medical physics, or clinical science backgrounds. We maintain device-specific terminology databases and use Translation Memory systems to ensure consistency across all documents in a submission package. Critical technical specifications are subject to independent review by a second qualified engineer-linguist.
Yes. We translate IEC 62304 software lifecycle documentation, AI/ML transparency documentation, cybersecurity risk assessments, and Software of Unknown Provenance (SOUP) lists for SaMD and digital health products. Our software documentation translators understand both the technical software engineering terminology and the regulatory requirements for SaMD submissions.
Ready to advance your medical devices program?
Contact our medical devices translation specialists. We respond within 15 minutes during business hours.
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