IVDR Gap-Assessment Tool incl. ISO 13485:2016

1,380.00 CHF

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 1 and 2 + transition provision 2023 + ref. to all affected ISO chapters)

We invested over 1000 hours to develop and optimize this IVDR Gap-Assessment Tool incl ISO 13485:2016 references. The integrated reference table helps to find the IVDR 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

Benefits:

  • Reference table to ISO 13485:2016
  • Including a Gap-Report
  • Including a Project-Plan
  • Free corrigendum updates until May 2022
  • 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

 

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Description

Description:

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

Benefit:

  • Comparison table between ISO 13485:2016 and IVDR
  • Including a Gap-Report
  • Including a Project-Plan
  • 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

Language:

  • English

Reference Documents:

  • ISO 13485:2016
  • EU 2017/746, English version of 5 May 2017
  • Corrigenda, 13th March 2019
  • Corrigenda, 27th December 2019
  • Corrigenda, 25th January 2022
  • Transition Provision 2023
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