WMDE

"Experience you can Trust"

Medical device regulatory affairs

Medical device regulatory affairs

WMDE B.V. can assist you with Regulatory Affairs for all classes of medical devices and IVD's since 1999.

WMDE B.V. can assist with:

  • Classification
  • Technical file review
  • Language requirements
  • European Representation
  • Packaging requirements
  • Labeling requirements
  • Registration
  • EUDAMED
  • Vigilance reporting
  • Medical device regulatory affairs
  • IVD regulatory affairs
  • Person resposible for regulatory compliance

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If you have any questions, please contact us by e-mail or telephone: +31 (0)475 58 22 85

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