Check out appendix A9 of MEDDEV 2.7.1 rev4, there is a suggested report format included in the guidance. You can easily make your own template based on that as a starting point.
my QM and me are arranging the last adjustments in the CERs of our medical devices. Once finished, we can forward you the PDF format of the document we have developped and used for this purpose.
my QM and me are arranging the last adjustments in the CERs of our medical devices. Once finished, we can forward you the PDF format of the document we have developped and used for this purpose.
We are redoing a CER for class II device and we have some issues with the v4 and its proper layout. Can I also ask for the copy of the PDF, I would greatly appreciate it.
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