Medical Device Labeling – Precision, Compliance, and Global Accessibility

Ensuring Accuracy, Compliance, and Patient Safety in Every Language.

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+880

CLiNICAL STUDIES

86

countries

+300

LAnguages

More Than Translation—A Matter of Patient Safety

Medical device labeling is more than just translation—it’s about patient safety, regulatory compliance, and clear communication. Every label, instruction, and user manual must meet the highest global standards while ensuring accessibility for diverse markets. At Welocalize, we combine linguistic precision, regulatory expertise, and AI-driven quality assurance to deliver medical device labeling solutions that are accurate, compliant, and globally consistent.

Compliance with Global Medical Regulations

Cardiology

Endocrinology

Genetic Diseases

Infectious Diseases

Neurology

Oncology

Accuracy in High-Stakes Environments

ClinROs

PROs/ePROs

ObsROs

COAs/eCOAs

Patient Diaries

Abstracts & Manuscripts

Scalable Labeling for Global Markets

ISO 9001:2015

ISO 13485:2016

ISO 17100:2015

ISO 18587:2017

ISO/IEC 27001:2013

ISO/IEC 27701:2019

Optimize Your Medical Device Labeling

for Compliance & Market Success

24-48 Hour Quote Turnaround

Our industry focus has made us experts in knowing exactly what’s
required to localize and validate your clinical documents with accuracy.

Reduced Translation Time

With a growing network of over 100,000 in-country linguistic
resources, you can expect industry-leading turnaround times.

[CASE STUDY] LINGUISTIC VALIDATION

Translation into 40 Language for 50-country Drug Trial

A successful collaboration with a private, billion-dollar Japanese company specializing in several therapeutic areas. We translated ten patient instruments used to measure medication effectiveness into 40 languages for a global drug trial.

Rigorous Quality Methodologies

Dual forward translation, clinician review, and cognitive debriefing ensure instruments are culturally relevant and psychometrically comparable.

Industry-Leading Accuracy

An industry-leading 7 ISO certifications support our translation and validation processes, hitting all quality assurance standards.

_{Client Success}“In order for an instrument to be used in international studies, it must address the same concepts in all languages in order to make it possible to pool data and compare results across countries. Welocalize provides linguistically and culturally accurate translations, which are critical components of pooling data across countries.”
_{Private Japanese Pharmaceutical}