Process of CE Marking of Medical Devices

  • Identify the products and models for CE Marking
  • Identify the experienced consulting team
  • Identify the Applicable directive
  • Identify the class of medical device
  • Implement Medical Device Quality Management system in your organization
  • Conduct Risk analysis
  • Identify the harmonized standards
  • Identify the laboratories for conducting the tests
  • Verify the test reports
  • Prepare Technical file
  • Identify the Notified Body if required
  • Review of technical file
  • Notified body audit
  • Affix CE Mark on successful completion

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