◆ Healthcare & Life Sciences

Medical software translation

Medical devices, clinical trials, regulatory submissions (NMPA, FDA, CE MDR), IFU documentation, and pharmaceutical inserts with validated linguistic quality protocols.

Discuter du projet Voir les scénarios

NDA entreprise · Conformité terminologique métier

Medical software translation Normes QA ISO 17100

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.

View Clinical Evaluation Case → →

Medical Device IFU & Software UI

Instructions for Use (IFUs), IVD reagent inserts, SaMD medical software UI strings, and safety alerts.

View Medical Device Case → →

Regulatory Dossiers (eCTD & CE MDR)

Technical dossiers, Clinical Evaluation Reports (CERs), and biocompatibility studies compliant with EU MDR and FDA 21 CFR.

View CE MDR Filing Case → →

Product Inserts (SmPC / PIL / Labels)

Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), packaging, and pharmacopoeia labels.

View Pharma Submission Case → →

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.

💡 Note: For Informed Consent Forms (ICFs), a forward + back-translation + clinician reconciliation workflow is recommended.

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 (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.

Voir tous les échantillons →

Medical Device IFU Translation Sample EN ➔ ZH-CN

Source (EN - Medical Device IFU Excerpt)

"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."

Target (ZH-CN - Regulatory Compliant Translation)

“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

Échantillon de référence Sample ID: IND-MED-01

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.

Voir tous les cas sectoriels →

◆ FAQ

Questions fréquentes

Tarifs, délais, confidentialité et formats de fichiers—contactez-nous pour toute autre question.

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Profil des linguistes pour Medical software translation ?

Traducteurs sectoriels, glossaires, checklists conformité, revue SME si besoin.

Expérience réglementaire ?

FDA/MDR, IEC, ISO selon le secteur—IFU, SOP, contrats, manuels.

Maintenance des contenus ?

TM, glossaires, mises à jour différentielles, chef de projet dédié.

Combien coûte Medical software translation ?

Le tarif dépend du volume, des langues, du domaine, des délais et du format. Envoyez un échantillon—réponse sous 24 h.

Quels facteurs influencent le prix ?

Paires linguistiques, type de contenu, DTP, certification, glossaire, urgence et volume récurrent.

Quels sont les délais habituels ?

Environ 2 000–3 000 mots source par jour pour les documents ; livraisons par phases pour web/logiciel.