Anonymized case Medical Devices · 6 weeks
Class II Device IFU Translation for FDA 510(k)
Translated IFU, labels and packaging copy for a Class II device US export aligned with 510(k) timeline.
Mutual NDA available on request · Industry QA standards applied
- Languages
- 2
- IFU pages
- 48
- Weeks
- 6
- FDA consultant review rounds
- 2
Background
The client is in medtech and life sciences, where filings must align with FDA, EU MDR, NMPA and similar frameworks. “Class II Device IFU Translation for FDA 510(k)” demands higher precision, traceability and confidentiality than typical business translation.
A first-time 510(k) submitter needed Chinese IFU and labels in FDA-appropriate English—warnings, contraindications and UDI aligned with source and US label artwork.
Linguist assigned industry linguists, reviewers and a dedicated PM. Scope included IFU translation, Label translation, 510(k) support, etc.. Within 6 weeks, we delivered and QA’d 2 languages—achieving: FDA consultant confirmed warning and UDI language meets 21 CFR expectations
血管介入导管使用说明书
适用范围 (Indications) · 禁忌证 (Contraindications)
中文：仅限一次性使用，严禁二次灭菌 · 环氧乙烷灭菌 (STERILE EO)
EN: Single use only. Do not resterilize (ISO 7000-1051).
储存于阴凉干燥处，避免阳光直射（15°C–25°C）· 包装破损严禁使用
Project challenges
-
Warning conventions
Warning hierarchy and symbols per FDA practice.
-
UDI & models
Model and lot rules unchanged.
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Figure alignment
Illustrated steps mapped line by line.
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Filing window
Final lock before 510(k) submission date.
Our approach
Phased delivery balancing quality, compliance and timeline.
- 01
Regulatory alignment
Confirm target markets, doc types and authority expectations.
- 02
Medical glossary
IFU/label/clinical glossary and do-not-translate lists.
- 03
Med TEP + DTP
Medical linguists, second review and layout fidelity.
- 04
Submission packaging
Organized deliverables per filing templates and change logs.
Deliverables
- English IFU
- Label copy
- 510(k) summary annex
- Terminology matrix
Project highlights
-
510(k) experience
Common IFU structures and review focus areas.
-
Warnings
Professional warning hierarchy handling.
-
Label sync
UDI and packaging copy aligned.
-
Final lock
Version tied to submission package.
Ready to Start Your Translation Project?
Our experienced team is ready to deliver high-quality translation services tailored to your industry and timeline.