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

[riri1912]

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.

 

[rob73]

Hi Riri
Welcome to the cove!
See this thread Clinical Evaluation Procedure example needed for examples of procedures.

 

[riri1912]

Hi Rob
Thank you very much for your help.

 

[riri1912]

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]

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.