Healthcare & Life Sciences
Medical device translation Registration · IFU · Clinical · QMS
For multinational pharmaceuticals, medical device manufacturers, CROs, and regulatory affairs teams. We deliver clinical study protocols, Instructions for Use (IFU), pharmacopoeia summaries, and regulatory dossiers compliant with FDA, EU MDR, and NMPA.
- Normes qualité ISO 17100
- Workflow de révision pro
- Gestion de projets multilingues
Key Industry Scenarios & Solutions
Comprehensive multilingual workflows for clinical research, medical device registration, and global pharmaceutical distribution.
Clinical Trials & Ethics Review
Clinical trial protocols, Informed Consent Forms (ICFs), Investigator's Brochures (IBs), and SAE reporting with uncompromising rigor.
Medical Device IFU & SaMD UI
Instructions for Use (IFUs), IVD reagent inserts, SaMD medical software UI strings, and patient safety alerts.
Regulatory Dossiers (eCTD & CE MDR)
Technical dossiers, Clinical Evaluation Reports (CERs), and biocompatibility studies compliant with EU MDR and FDA 21 CFR.
Package Inserts & Labels (SmPC / PIL)
Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), packaging labels, and pharmacopoeia compliance.
Project Preparation
The following information helps align regulatory frameworks and match specialized medical reviewers.
Source Files
Provide clinical protocols, regulatory dossiers, medical device IFUs, or patient leaflets (Word, InDesign, PDF, XML).
Target Languages & Markets
Specify target submission countries, languages, and regulatory frameworks (FDA, EU MDR, NMPA, PMDA).
Purpose & Audience
Clarify submission context (health authority review, clinical trials, patient signing, device packaging).
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.
Flux traduction et qualité sectorielle
Boucle fermée : terminologie, traduction experte, double relecture et mise en page.
Périmètre et terminologie
Analyser structures et calques, extraire les termes métier.
Traduction experte
Traducteurs spécialisés santé, IT, juridique ou ingénierie.
Double relecture et QA numérique
Vérifier tolérances, alertes et références réglementaires.
Mise en page et renvois
Préserver hiérarchie, renvois et alignement structurel.
Livraison et mémoire
Livrer fichiers et journaux QA, archiver la terminologie client.
Deliverables
Les livrables sont définis selon le périmètre convenu.
Deliverables
- Regulatory-compliant final translated documents (FDA / EU MDR / NMPA)
- 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 | 药物洗脱冠状动脉支架系统 | NMPA Standard Device Nomenclature |
| Sirolimus | 西罗莫司 | Official Pharmacopoeia Drug Name |
| Active Bleeding Diathesis | 活动性出血倾向 | MedDRA Standard Symptom Nomenclature |
Cardiovascular Drug-Eluting Stent System IFU
Industry: Healthcare & Life Sciences · Standard: EU MDR 2017/745 & FDA 21 CFR
Official Device Nomenclature
Strictly aligned with official medical device classification guidance.
Zero Tolerance for Ambiguity
Zero tolerance for ambiguity across contraindications and adverse events.
Clinician Specialist Review
Second-pass review by medical practitioners and regulatory affairs specialists.
Ressources associées
Découvrez services, solutions sectorielles et études de cas connexes.
Services associés
Solutions sectorielles
- IFU translationMedical device IFU translation with strict warning, illustration and layout alignment for FDA/MDR filings.
- MDR translationEU MDR 2017/745 technical files, clinical evaluation, PMCF and DoC—aligned with notified body review language.
- FDA translationFDA 510(k), PMA, Q-sub and labeling/IFU translation aligned with US FDA formats and terminology.
Échantillon de glossaire spécialisé (TermBase) & Normes
Verrouillage terminologique en temps réel pour une précision technique absolue.
| Terme source & Spécification | Traduction cible standardisée | Contexte normatif | 状态 |
|---|---|---|---|
| 额定短路分断能力 (Icu) | Rated Ultimate Short-Circuit Breaking Capacity | IEC 60947-2 / GB 14048.2 | 🔒 Terme verrouillé |
| 绝缘栅双极型晶体管 (IGBT) | Insulated-Gate Bipolar Transistor | IEEE Standard / Automotive | 🔒 Terme verrouillé |
| 形位公差与基准面定义 | Geometric Dimensioning & Tolerancing (GD&T) | ISO 1101 / ASME Y14.5 | 🔒 Terme verrouillé |
| 压铸模具热平衡热流道系统 | Die Casting Thermal Balance Hot Runner System | VDI 3133 / Tooling Spec | 🔒 Terme verrouillé |
Questions fréquentes
Tarifs, délais, confidentialité et formats de fichiers—contactez-nous pour toute autre question.
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