Anonymized case

Medical Devices · 5 weeks

FDA Medical Device Labeling & Promotional Materials

Translated labels, packaging, brochures and website claims with FDA promotional material compliance review.

Result Regulatory consultant cleared off-label risk; trilingual labels launched together
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Mutual NDA available on request · Industry QA standards applied

Languages
3
Weeks
5
SKU labels
12
Compliance flags
0

Background

Industry: Medical Devices Timeline: 5 weeks Languages: Chinese, English, Spanish Services: Label translation, Promotional copy, Compliance review, etc.

The client is in medtech and life sciences, where filings must align with FDA, EU MDR, NMPA and similar frameworks. “FDA Medical Device Labeling & Promotional Materials” demands higher precision, traceability and confidentiality than typical business translation.

A client launching the same device in the US and Latin America needed EN/ES labels and promotional copy without off-label claims—aligned with cleared IFU indications.

Linguist assigned industry linguists, reviewers and a dedicated PM. Scope included Label translation, Promotional copy, Compliance review, etc.. Within 5 weeks, we delivered and QA’d 3 languages—achieving: Regulatory consultant cleared off-label risk; trilingual labels launched together

Project challenges

  • Promotional compliance

    Copy must not exceed cleared indications.

  • LATAM Spanish

    US Spanish vs. Latin American conventions.

  • Omnichannel consistency

    Labels, web and event materials unified.

  • Launch sync

    Label finalization aligned with production.

Our approach

Phased delivery balancing quality, compliance and timeline.

  1. 01

    Regulatory alignment

    Confirm target markets, doc types and authority expectations.

  2. 02

    Medical glossary

    IFU/label/clinical glossary and do-not-translate lists.

  3. 03

    Med TEP + DTP

    Medical linguists, second review and layout fidelity.

  4. 04

    Submission packaging

    Organized deliverables per filing templates and change logs.

Deliverables

  • Product labels
  • Packaging copy
  • Brochures
  • Website medical claims

Project highlights

  • Labeling

    UDI, symbols and warnings.

  • Promo compliance

    Joint review with regulatory counsel.

  • LATAM Spanish

    Variant handling.

  • Omnichannel

    Unified online/offline terms.

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