Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template

#1
Hi
I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation for a medical device
Does any one have an exemple or template of (regarding to the recommendation of the Meddev 2.7/1 révision 4 and new EU regulation) :
- a clinical investigation procedure
- a clinical evaluation and post market clinical follow up procedure
- clinical evaluation report
thank you.
 
#4
Hi Rob
Thank you very much for your help :)
Do you have a template for the clinical investigation procedure and the clinical evaluation and post market clinical follow up procedure ?
Because I just found only the Clinical Evaluation Report Guidance notes.
Thank you again
Riri
 

gary

Registered
#5
Hi
I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation for a medical device
Does any one have an exemple or template of (regarding to the recommendation of the Meddev 2.7/1 révision 4 and new EU regulation) :
- a clinical investigation procedure
- a clinical evaluation and post market clinical follow up procedure
- clinical evaluation report
thank you.
Hi Riri - did you receive any templates. If so please could I have a copy. Also I found this article very helpful.
 

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