FDA Medical Device Labeling & Promotional Materials
Translated labels, packaging, brochures and website claims with FDA promotional material compliance review.
Background
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
Outcomes
Regulatory consultant cleared off-label risk; trilingual labels launched together
Services:
Languages:
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.
Regulatory alignment
Confirm target markets, doc types and authority expectations.
Medical glossary
IFU/label/clinical glossary and do-not-translate lists.
Med TEP + DTP
Medical linguists, second review and layout fidelity.
Submission packaging
Organized deliverables per filing templates and change logs.
Deliverables
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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