FDA vs. EU MDR Technical Documentation Matrix

Download a free matrix (PDF)

This matrix will show you the differences between requirements of the U.S. Food and Drug Administration (FDA) and the MDR for technical documentation. The side-by-side comparison will allow you to easily:

  • Understand the medical device classification rules
  • Learn the difference between the approval process on the U.S. and EU markets
  • Prepare the required technical documentation with as little stress as possible
8-step transition process from MDD to MDR

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