FDA Medical Device Labeling & Promotional Materials
Translated labels, packaging, brochures and website claims with FDA promotional material compliance review.
Hintergrund
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.
Ergebnisse
Regulatory consultant cleared off-label risk; trilingual labels launched together
Leistungen:
Sprachen:
Projektherausforderungen
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.
Unser Vorgehen
Phasenweise Lieferung mit Balance aus Qualität, Compliance und Termin.
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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