It is virtually impossible to keep compliance with the EU regulations based on printed paper. This also holds true for the regulations themselves. Instead of working through the PDF we recommend to use our spreadsheets. Make your annotations digitally and benefit from
If you work in a team the biggest problem is keeping everything in synch in real time.
MDR / IVDR database as a web-service delivers perfectly synchronized efficiency with additional documentation management and many more excellent features.
On a corporate level with thousands of devices the MDR /IVDR transition is calling for complex transformations.
The MDR/IVDR corporate edition is the solution for management of multiple products and variants.