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.
Industry Translation & Quality Workflow
Enforcing closed-loop workflows from terminology extraction and SME translation to layout alignment.
Scope & Terminology Extraction
Analyze document structures, drawing layers, and extract vertical domain terms into glossaries.
Domain Expert Translation
Match specialized translators with healthcare, IT, legal, or engineering backgrounds.
Dual Review & Numeric QA
Cross-verification of technical tolerances, safety alerts, and regulatory references.
Layout Inspection & Callout Sync
Preserving document hierarchy, callout references, and structural alignment per source conditions.
Handover & TM Archival
Deliver final files, QA audit logs, and archive confirmed termbases into customer TM.
Deliverables
The following deliverables are tailored per agreed project scope.
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.
Frequently asked questions
Common questions on pricing, turnaround, confidentiality and file formats—contact us for anything else.
Ready to Start Your Project?
Submit your requirements and files. Our consultant will provide a transparent quote and timeline within 24 hours.
What linguist profile do you use for Medical software translation?
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How much does Medical software translation cost?
What factors affect translation pricing?
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Ready to Start Your Project?
Submit your requirements and files. Our consultant will provide a transparent quote and timeline within 24 hours.
Discuss Your Medical software translation Project
Submit technical drawings or draft chapters for a professional feasibility assessment.