The Role of Regulatory Bodies in the Medical Device Translation Process

Lexology October 10, 2024
Questel

For life sciences companies developing and distributing medical devices internationally, meeting the translation requirements set by regulatory bodies is a crucial step in bringing products to market. Regulatory compliance is a complex process that involves precise communication across languages, and translation plays a key role in ensuring that product information is both accurate and accessible for different markets. In this blog, we will cover the role of regulatory bodies in the medical device translation process, the specific requirements companies need to meet, and best practices for navigating regulatory expectations.

How Regulatory Bodies Impact Medical Device Translation

Regulatory bodies around the world establish guidelines that govern every aspect of a medical device, including its labeling, user manuals, safety information, and marketing...

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