IVDR Gap-Assessment Tool incl. ISO 13485:2016

1,380.00 CHF incl. VAT

This IVDR Gap-Assessment tool is ideal to use if you have the ISO 13485:2016 already in place and would like to integrate the IVDR on top. (Full version includes the complete IVDR + Corrigenda, March 2019 and ref. to all affected ISO chapters)



This IVDR Gap-Assessment tool is very helpful when you already have the ISO 13485:2016 in place.


  • Comparison table between ISO 13485:2016 and IVDR
  • Economic Operators search function included
  • Complete table of content of IVDR (Chapter, Annexes, incl. all articles)
  • Significant saving of working hours
  • Unique keyword search function

Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016


  • English

Reference Documents:

  • ISO 13485:2016
  • EU 2017/746, English version of 5 May 2017
  • Corrigenda, 13 March 2019
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