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)
Test Version
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
Our Payment Partners:
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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