Regulatory Language Requirements for Medical Devices in the European Union

European markets pose increasing regulatory language requirements for medical device manufacturers. These regulations 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.

Download the FREE Whitepaper and overcome those language challenges!

The whitepaper covers everything you need to know:

  • The Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • The CE Mark 
  • FDA and FD&C provisions
  • EUDAMED, the database for all Medical Devices sold to European markets
  • Global Harmonization and International Quality Standards

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