Medical Device Documentation Translation
Desktop Publishing (DTP)
Education & E-Learning
Client
MedTech Solutions
Languages
German, French, Spanish, Japanese, Chinese, Portuguese, Italian, Korean
Overview
Translation of comprehensive medical device documentation including user manuals, safety instructions, and regulatory submissions for FDA and EU MDR compliance.
The Challenge
Strict regulatory requirements demanded precise medical terminology and compliance with both FDA and EU MDR standards across multiple languages.
Our Solution
Our certified medical translators with domain expertise handled all content, followed by review from regulatory specialists to ensure compliance with all applicable standards.
The Results
All translations passed regulatory review on first submission. The client achieved market authorization in 8 countries within their target timeline.