Medical software translation
Medical devices, clinical trials, regulatory submissions (NMPA, FDA, CE MDR), IFU documentation, and pharmaceutical inserts with validated linguistic quality protocols.
Key Industry Scenarios
Multilingual solutions compliant with global regulatory standards for clinical trials, medical device filings, and pharmaceutical distribution.
Clinical Trials & IRB Documents
Clinical protocols, Informed Consent Forms (ICFs), Investigator Brochures (IBs), and SAE reporting with rigorous ethical precision.
Medical Device IFU & Software UI
Instructions for Use (IFUs), IVD reagent inserts, SaMD medical software UI strings, and safety alerts.
Regulatory Dossiers (eCTD & CE MDR)
Technical dossiers, Clinical Evaluation Reports (CERs), and biocompatibility studies compliant with EU MDR and FDA 21 CFR.
Product Inserts (SmPC / PIL / Labels)
Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), packaging, and pharmacopoeia labels.
Project Preparation
The following information helps align regulatory frameworks and match specialized medical reviewers.
Source Files
Provide clinical protocols, registration dossiers, medical device IFUs, or manuals (Word, InDesign, PDF, XML).
Target Languages
Specify target submission countries, languages, and regulatory frameworks (NMPA, FDA, EU MDR, PMDA).
Purpose & Audience
Clarify filing context (regulatory submission, clinical trials, ICF patient signing, device package inserts).
Terminology & References
Submit legacy glossaries, MedDRA/WHO-ART coding rules, or previous registration archives.
Format & Timeline
Clarify if back-translation, ethics certificates, or expedited milestone turnarounds are required.
산업 번역 및 품질 관리 프로세스
용어 추출부터 전문가 번역, 이중 감수, 레이아웃 정합까지 폐쇄형 워크플로.
범위 및 용어 추출
문서 구조와 도면 레이어를 분석하고 도메인 용어를 추출합니다.
도메인 전문가 번역
의료·IT·법률·엔지니어링 배경의 전문 번역가가 초역합니다.
이중 감수 및 수치 QA
공차, 안전 경고, 규정 참조를 교차 검증합니다.
레이아웃·콜아웃 정합
문서 계층과 콜아웃 참조를 소스 조건에 맞게 검사합니다.
납품 및 TM 보관
최종 파일과 QA 기록을 납품하고 용어를 고객 TM에 보관합니다.
Deliverables
납품물은 합의된 프로젝트 범위에 따라 정의됩니다.
Deliverables
- Regulatory-compliant final translated documents (NMPA / FDA / CE MDR)
- Back-translation and clinician reconciliation reports
- Signed Certificate of Medical Translation Accuracy
- MedDRA and pharmacopoeia aligned medical glossaries
Prerequisites & Scope Notes
- Regulatory Scope: Translation certifies language fidelity; clinical study design remains sponsor responsibility
- Layman's Language: ICFs require balancing medical precision with 6th-8th grade reading comprehension
- eCTD Specifications: Granular PDF bookmarking and cross-linking specifications must be agreed
- IRB Submission Windows: Expedited reviewer assignments available for impending IRB deadlines
Medical Device IFU Translation Sample
Demonstrating cardiovascular stent IFU contraindications, parameters, and MedDRA terminology standards.
"CONTRAINDICATION: The drug-eluting coronary stent system is contraindicated in patients with known hypersensitivity to sirolimus or bioabsorbable polymer coatings, or with active bleeding diathesis."
“禁忌症：本药物洗脱冠状动脉支架系统禁用于对西罗莫司或生物可吸收聚合物涂层存在已知过敏史，或伴有活动性出血倾向的患者。”
| Source Medical Term | Regulatory Target Term | Standard & Class |
|---|---|---|
| Drug-Eluting Coronary Stent System | Drug-Eluting Coronary Stent System | NMPA Standard Device Nomenclature |
| Sirolimus | Sirolimus | Chinese Pharmacopoeia Official Drug Name |
| Active Bleeding Diathesis | Active Bleeding Diathesis | MedDRA Standard Symptom Nomenclature |
Cardiovascular Drug-Eluting Stent System IFU
Industry: Healthcare & Life Sciences · Standard: EU MDR 2017/745 & NMPA
NMPA Device Nomenclature
Strictly aligned with official medical device classification guidance.
Uncompromising Safety Alerts
Zero tolerance for ambiguity across contraindications and adverse events.
Clinical Specialist Review
Second-pass review by medical practitioners and regulatory affairs specialists.
자주 묻는 질문
견적, 납기, 기밀 유지, 파일 형식에 대한 일반적인 질문입니다.
프로젝트를 시작할 준비가 되셨나요?
요구사항과 파일을 제출해 주세요. 24시간 내 투명한 견적과 일정을 안내드립니다.
Medical software translation 분야 번역가 요건은?
규제·표준 문서 경험?
장기 콘텐츠 유지 방법?
Medical software translation 비용은 어떻게 산정되나요?
가격에 영향을 주는 요소는?
납기는 보통 얼마나 걸리나요?
프로젝트를 시작할 준비가 되셨나요?
요구사항과 파일을 제출해 주세요. 24시간 내 투명한 견적과 일정을 안내드립니다.
Medical software translation 프로젝트 상담
기술 도면이나 샘플을 제출해 주시면 타당성 평가를 제공합니다.