Clinical Evaluation Procedure example needed

[KAMay]

I recently sat in on the external audit of another company (technically we're two companies under one roof) at the end of the audit, the auditor, familiar with the company I work for, commented 'of course you will be updating your Clinical Evaluation procedure to be in line with the newly revised MEDDEV' - 'of course I will' I replied..

I've just pulled out our current procedures manual and WE DON'T HAVE A PROCEDURE AT ALL. Can anyone help me out with an example of a sop?

(and how have they not noticed before... ha!)

thanks

 

[Stijloor]

I recently sat in on the external audit of another company (technically we're two companies under one roof) at the end of the audit, the auditor, familiar with the company I work for, commented 'of course you will be updating your Clinical Evaluation procedure to be in line with the newly revised MEDDEV' - 'of course I will' I replied..

I've just pulled out our current procedures manual and WE DON'T HAVE A PROCEDURE AT ALL. Can anyone help me out with an example of a sop?

(and how have they not noticed before... ha!)

thanks

I know it's a weekend, but does anyone have a sample of this procedure?

Thanks!

Stijloor.

 

[SteveK]

I just use a form (see attached), I do not think a procedure is a requirement. My NB seemed OK with this so long as you do not just cite a journal etc reference, but include an approriate extract of the document.

 

[rob73]

This is a more complicated based on MEDDEV 2.7.1 rev 3, depending on what class of device you are looking at will determine which path to follow.

Rob

 

[KAMay]

thanks guys, I didn't realise there had been any replies so sorry for the delay

 

[tonydavid]

Have you managed to source a clinical evaluation procedure? as I need help too

 

[Ronen E]

https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native

 

[rob73]

These are ours, not sure how they would stand up to audit as they have never been examined by an auditor (we only manufacture class 1 devices)

 

[mikinnear]

Thanks all, solved a bit of an issue for me today!