MDSAP vs. ISO 13485:2016 Checklist

299.00 CHF

The MDSAP vs. ISO 13485:2016 checklist support you to assess all requirements and help to track those during the implementation phase. (Based on the MDSAP Companion document AU P0002.008)

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This tool is Excel-based because:

– No software installation required
– Your highly sensitive data are 100% under your control
– You do not have to trust any third parties


  • Simple overview / No paper chaos
  • Easy to sort by specific county requirements
  • The checklist supports well during the implementation
  • Helpful overview during the next MDSAP audit


What you get:

  • Instruction for use
  • Technical Support
  • Customer feedback improved tool



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Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016


  • English

Reference Documents:

  • MDSAP Companion Document (FDA: AU P0002.008)
  • ISO 13485:2016
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