Selling your medical device in the global marketplace requires you to consider other languages and cultures. There are over 20 official languages in Europe alone and thousands more worldwide. How is it possible to provide necessary information about your medical device to a diverse group of users?
The use of symbols and the adoption of electronic labeling (e-labeling), where possible, help simplify product labeling while also providing sufficient information for users. In this white paper, we'll answer your biggest questions about standards, requirements, and symbols for medical device labeling, including:
- What are the Essential Requirements for medical device labeling and languages?
- What are the benefits of symbols?
- What are the harmonized standards?
- What symbols are available and what do they mean? (Index)
- Is e-labeling an option for medical device manufacturers?
- What are the best practices for medical device labeling?
About the Authors
Jennifer Tribbett is Director of Regulatory Affairs at Emergo. With more than 25 years of experience in the medical device industry, Jennifer's areas of expertise include domestic and international regulatory submissions including 510(k) submissions, EU technical file compilation and assessment as well as Quality Management System (QMS) implementation and compliance. Before joining Emergo, she was a Regulatory Program Manager at Roche Diagnostics.
Megan Gottlieb is a Global Regulatory Research Associate at Emergo. Megan has a background in the EU medical device regulatory system and performs research on regulatory regimes for all global markets. She holds a Bachelor of Arts in International Relations and Global Studies from The University of Texas at Austin.