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Regulatory Globe|2 December 2020

IVDR GAP-Assessment Tool

Our IVDR gap assessment tool is our basic version. This tool contains complete IVDR with all chapters (1 - 10) and appendices (1-15).

Our IVDR gap assessment tool is our basic version. This tool contains complete IVDR with all chapters (1 – 10) and appendices (1-15). It contains a table of contents and a search function with which you can quickly search through the IVDR for certain keywords. (Tool is up to date: Incl. Corrigenda 1 and 2).

Why use our IVDR GAP-Assessment Tool:

In the last 3 years, we invested over 600 hours to develop and optimize our IVDR Gap-Assessment Tool to have the best tools in the medical device space. Download our test version today to get a first impression of how it works, and how powerful this tool can be.

Benefits:

  • Free corrigendum updates until May 2022
  • Significant saving of working hours
  • Very simple to use
  • 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

IVDR Premium Tools:

IVDD vs IVDR Gap-Assessment Tool.

IVDR Gap-Assessment Tool incl. ISO 13485:2016 references.

See the differences between those tools in the following table below:

For manufacturers who are not established in the Union, the EU Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced...
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