MDD vs MDR Gap-Assessment Tool

1,090.00 CHF

This MDD vs MDR Gap-Assessment tool includes additional to the gap-assessment section also a correlation table from MDD to MDR. This supports you to evaluate all your gaps in your Company. (Full version includes the complete MDR + Corrigenda 1 and 2 + Updated with May 26, 2021 + correlation table to MDD + transition provision 2023)

 

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MedBoard and Regulatory Globe invested over 1000 hours to develop and optimize this MDR vs MDD Gap-Assessment Tool. The integrated correlation table between MDD and MDR 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 MDD and MDR
  • Wording Gap-Analysis between MDD and MDR
  • 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:

  • Methodology of how to reduce requirements
  • Instruction for use
  • Technical Support
  • Customer feedback improved tool

 

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Description

Description:

This Gap-Assessment Tool has included the complete MDR EU2017/745 and a comparison table to the MDD 93/42/EEC. Therefore, this tool is very helpful for all Medical Devices companies which have to change from MDD to MDR.

In cooperation with MedBoard Company Ltd.

Benefits:

  • 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 2017/745, English version of 5 May 2017
  • Corrigenda, 13. March 2019
  • Corrigenda, 27. December 2019
  • MDD 93/42/EEC
  • Amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (24. April 2020)
  • Transition Provision March 2023
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