Medical Qualification


  • Over 200 qualified projects
  • Harmonized documentation across the North American, European and Asian markets.
  • Provided documents follow the GAMP, EU GMP, ICH and FDA guidelines and regulations
  • Qualification package can be adapted to customer’s needs

Benefits of our validated standard platforms

  • Risk mitigation: many functions are already covered by the standard platform qualification
  • Quality: the standard doesn’t need to be qualified on each project
  • Time optimization: the Mikron team is focused on customer specific processes
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