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Regulatory Language Requirements for Medical Devices in the EU

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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

Sign up below and download the free whitepaper to meet the language requirements and increase customer satisfaction!

If you want to learn more about the areas that will be affected once the new Medical Device Regulation comes into effect, check mdreurope.com

Register to download our FREE EU MDR IFU Guide and to get exclusive access to all our other MDR resources.

Regulatory Language Requirements for Medical Devices in the EU

Sign up and download the FREE Whitepaper now!






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