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 + 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.
– No software installation required
– Your highly sensitive data are 100% under your control
– You do not have to trust any third parties
This IVDR Gap-Assessment tool is very helpful when you already have the ISO 13485:2016 in place.
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