IVDD vs IVDR Gap-Assessment Tool

1,090.00 CHF

This IVDD vs IVDR Gap-Assessment / Comparison Tool supports you to evaluate all your gaps in your Company. (Full version includes the complete IVDR + Corrigenda, March 2019 + correlation table to IVDD)

 

Developed in cooperation with: 

 

MedBoard and Regulatory Globe invested over 1000 hours to develop and optimize this IVDR vs IVDD Gap-Assessment Tool. The integrated correlation table between IVDD and IVDR will help to get a much deeper understanding of the upcoming changes and helps to reduce requirements much faster. 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:

  • Visual correlation between IVDD and IVDR
  • Wording Gap-Analysis between IVDD and IVDR
  • 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

 

Category: Tags: ,
Description

Description:

Includes the complete IVDR EU2017/746  and helps to assess your gaps.

This Gap-Assessment Tool has included the complete IVDR EU2017/746 and a comparison table to the IVDD 98/79/EC. Therefore, this tool is very helpful for all medical device companies which have to change from IVDD to IVDR.

In cooperation with MedBoard Company Ltd.

Benefits:

  • Correlation table between IVDD and IVDR
  • Complete table of content (Chapter, Annexes, incl. all articles)
  • Very simple to use
  • Significant saving of working hours
  • Unique keyword search function

Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016

Language:

  • English

Reference Documents:

  • EU 2017/746, English version of 5 May 2017
  • IVDR Corrigenda, 13 March 2019
  • IVDD 98/79 EC
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