Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice?

[Sue789]

What is the difference between an Advisory Notice (ISO 13485) and a Field Safety Notice?

Is there a document that tells me what goes into an Advisory Notice?

Thank you in advance for the help/

 

[Al Rosen]

What is the difference between an Advisory Notice (ISO 13485) and a Field Safety Notice?

Is there a document that tells me what goes into an Advisory Notice?

Thank you in advance for the help/

Scroll down towards the bottom of this page to find other threads on the subject of advisory notices that may answer your question.

 

[Sue789]

Thanks for the reply I have read the GHTF document SG2/N57R8:2006 content of Field Safety Notices and was trying to ascertain if this information is the same as an Advisory Notice.

After reading to me it looks the same but just want confirmation.

 

[somashekar]

Thanks for the reply I have read the GHTF document SG2/N57R8:2006 content of Field Safety Notices and was trying to ascertain if this information is the same as an Advisory Notice.

After reading to me it looks the same but just want confirmation.

As you see the Terms and Definitions at 3.1 in the ISO 13485, Advisory notice is the word that is used in several instances like Use, Modification, Return, Distruction, of the Medical device. Hence a Field safety notice becomes a type of Advisory notice.