MDR Gap-Assessment Tool incl. ISO 13485:2016

1,380.00 CHF

This MDR Gap-Assessment tool is ideal to use if you have the ISO 13485:2016 already in place and would like to integrate the MDR on top. (Full version includes the complete MDR + Corrigenda 1 and 2 + Updated to May 26, 2021 + ref. to all affected ISO chapters)

Developed in cooperation with: 


QUNIQUE and Regulatory Globe invested over 1000 hours to develop and optimize this MDR Gap-Assessment Tool incl ISO 13485:2016 references. The integrated reference table helps to find the MDR impacts on your QMS immediately. Download our test version today to get a first impression of how it works, and how powerful this correlation table can be.

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


  • Reference table to ISO 13485:2016
  • Including a Gap-Report
  • Including a Project-Plan
  • Free corrigendum updates until May 2021
  • Significant saving of working hours
  • Unique keyword search function
  • Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

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


Our Payment Partners:



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


  • Comparison table between ISO 13485:2016 and MDR
  • Including a Gap-Report
  • Including a Project-Plan
  • Economic Operators search function included
  • Complete table of content of MDR (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 2017/745, English version of 5 May 2017
  • Corrigenda, 13. March 2019
  • Corrigenda, 27. December 2019
  • Amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (24. April 2020)
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