◆ 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.

Projekt besprechen Szenarien ansehen

Unternehmens-NDA · Branchenterminologie

Medical software translation ISO-17100-QA-Standards

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.

Branchenübersetzung und QA-Prozess

Geschlossener Ablauf von Terminologie und Fachübersetzung bis Layout-Abstimmung.

Scope und Terminologie

Strukturen und Layer analysieren, Fachbegriffe extrahieren.

Fachübersetzung

Spezialisierte Übersetzer für Medizin, IT, Recht oder Technik.

Doppelprüfung und Zahlen-QA

Toleranzen, Warnungen und Normenreferenzen prüfen.

Layout und Callouts

Hierarchie und Bezüge gemäß Quelle sichern.

Übergabe und TM

Dateien und QA-Logs liefern, Termine im Kunden-TM archivieren.

Deliverables

Deliverables werden gemäß vereinbartem Scope definiert.

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.

Alle Beispiele →

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

Referenzbeispiel 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.

Alle Branchenfälle →

◆ FAQ

Häufige Fragen

Preise, Fristen, Vertraulichkeit und Dateiformate—bei weiteren Fragen kontaktieren Sie uns.

Bereit für Ihr Projekt?

Senden Sie Anforderungen und Dateien. Transparentes Angebot und Zeitplan innerhalb von 24 Stunden.

✓ Gegenseitige NDA möglich

✓ Bewertung innerhalb von 24 Stunden

✓ Transparente Preise & Scope

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Welches Linguisten-Profil für Medical software translation?

Branchenerfahrene Linguisten, Glossare, Compliance-Checklisten, SME-Review bei Bedarf.

Regulatorische Dokumente?

FDA/MDR, IEC, ISO je nach Branche—IFU, SOPs, Verträge, Handbücher.

Langfristige Pflege?

TM, Glossare, Diff-Updates, dedizierter PM, Release-Rhythmus.

Was kostet Medical software translation?

Preis nach Umfang, Sprachpaar, Fachgebiet, Frist und Format. Muster senden—Antwort innerhalb von 24 Stunden.

Welche Faktoren beeinflussen den Preis?

Sprachpaar, Inhaltstyp, DTP, Beglaubigung, Glossar, Eiligkeit und Projektvolumen.

Wie lange dauert die Lieferung?

Ca. 2.000–3.000 Quellwörter pro Tag bei Dokumenten; phasenweise bei Web/Software.