Clinical Evaluation sample for X-Ray Machine

#1
Now i'm preparing tecnical file construction for CE MDD audit.
our NB auditor told me that clinical evaluation audit is getting more stric so in many cases receive complement letter from NB.

could i get a good sample for clinical evluation report?
now i'm under stress....:bonk:
 
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#2
Now i'm preparing tecnical file construction for CE MDD audit.
our NB auditor told me that clinical evaluation audit is getting more stric so in many cases receive complement letter from NB.

could i get a good sample for clinical evluation report?
now i'm under stress....:bonk:
Hi

Have you gone through the EU- MEDDEV.2.7.1 Rev.3 guidance?.

This guidance document provides a general principles of clinical evaluation, how to identify relevant clinical data to be used in a clinical evaluation, how to appraise and integrate clinical data into a summary & how to document a clinical evaluation in a clinical evaluation report. Also, you can find a "Clinical evaluation checklist for Notified Bodies" (APPENDIX F - Page 35 of 46) within this guidance document.
 
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