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More and more language requirements in the EU

European markets pose increasing regulatory challenges for medical device manufacturers. These regulations are controlling manufacturing, marketing, and usage of medical devices in the EU and force manufacturers to incorporate language translation and localization into global development strategies as individual Member States demand product information in the language of the local user. 

Thus, a simultaneous global release of medical devices involving up to 24 languages in Europe alone might be a critical issue. Medical device manufacturers have to find a cost-effective strategy to market their products globally, while satisfying international regulatory requirements. 

Download our FREE Whitepaper!

Do you want to know more about the language requirements in the EU? Then download our FREE whitepaper! The whitepaper covers everything you need to know to effectively meet the language requirements and increase customer satisfaction:

  • The Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • The CE Mark – A passport to the EU
  • Exporting American Medical Devices – FDA and FD&C provisions
  • Documentation Translation Requirements – EUDAMED, the database for all Medical Devices sold to European markets
  • Global Harmonization and International Quality Standards

whitepaper about regulatory language