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.
業界翻訳と品質管理フロー
用語抽出、専門家翻訳、二重校閲、レイアウト整合までのクローズドループ。
範囲と用語抽出
文書構造・図面レイヤを解析し、分野用語を用語集に抽出。
分野専門家による翻訳
医療・IT・法務・工学背景の専門翻訳者が初訳。
二重校閲と数値QA
公差・安全警告・規格参照を逐文照合。
レイアウトと引出線整合
階層・引出線・構造をソース条件に合わせて検査。
納品とTM保管
最終成果物とQA記録を納品し、用語を顧客TMへ保管。
Deliverables
成果物は合意したプロジェクト範囲に応じて定義します。
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.
よくある質問
見積もり、納期、機密保持、ファイル形式に関する一般的な質問です。
プロジェクトを始めますか？
要件とファイルをご共有ください。24時間以内に見積もりと納期案をご案内します。
Medical software translation向けの翻訳者要件は？
規制・標準文書の経験は？
継続更新の運用は？
Medical software translationの費用はどのくらいですか？
価格に影響する要素は？
納期の目安は？
プロジェクトを始めますか？
要件とファイルをご共有ください。24時間以内に見積もりと納期案をご案内します。
Medical software translationプロジェクトについて相談する
技術図面やサンプルをご共有ください。実現可能性を評価します。