A signed mutual recognition agreement (MRA) between the EU and Switzerland by 26 May 2021...
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.
- 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: