Client Challenge
Medical imaging solutions manufacturer TEAC Europe GmbH reached out to Avantpage Life Sciences with a two-fold request. Their most recent IFU needed translation into five languages. However, they had not yet been able to conduct the necessary check, on the English text, for regulatory compliance with EU standards.
With over 20 years of experience providing regulatory medical writing, Emtex Life Science’s compliance specialists kicked off the project, sending approved content to Avantpage’s expert linguists for translation.
Solution and Project Steps
Emtex Life Science checks compliance of English text against EU MDR regulations
Compliance-approved English text is sent to Avantpage for proofreading – 17K words
Translation into five languages: French, German, Italian, Spanish, and Turkish
Each translated file is reformatted by Avantpage’s graphic design team
Files are delivered to the client, and a post-project glossary is created for future use
About Avantpage Life Sciences
About Emtex Life Science
“This was the first time we worked with a different vendor and also the first time we asked an external partner to check MDR compliance. Things were very smooth with Avantpage/Emtex Life Science, who will soon begin assisting with the complex IFU update process.” Andreas Koller, Sales and Marketing Manager, TEAC Europe GmbH