CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted

[Europeancut]

I need a CER MEDDEV Version 4 Template, Can anyone help me?

 

[yodon]

Re: CER Template

Similar request here: Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template

 

[karha096]

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.

 

[Girija VCL]

Hi,

Am currently working in a class III medical device organisation,can somebody provide me a customer feedback form.

Thanks in advance,

 

[AlessiaMaggi]

Dear all,

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.

Alessia

 

[medim]

Dear all,

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.

Alessia

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.