A
Hi all,
I need to incorporate an advisory notice procedure into our existing QPM - we currently state that we will issue an advisory notice if it becomes necessary but there are no details on the process ...I understand the definition of the advisory notice and (I think) when it should be performed, but what I'm trying to find out is if there are any particular requirements (or suggestions from brilliant minds on the forum
) for what that advisory notice form should like and what the procedure should entail?
FYI: I started looking because we have kits in a distributors warehouse which currently hold items that we (the manufacturer) would like to pull out of the kit. From what I can tell an advisory notice is warranted here - there is no danger from the item, the test will perform to specs without the item and the item has been historically offered as a complement to the test....but we want to discontinue that practice. In order to effect the change for kits currently in the distributors warehouse, from what I can tell under 3.3 "modification of a medical device' an advisory notice would be the way to go.
Am I on the right track here?
~ And if yes, does anyone have any suggestions on the procedure and/or form?
Thanks so much!
Amanda
I need to incorporate an advisory notice procedure into our existing QPM - we currently state that we will issue an advisory notice if it becomes necessary but there are no details on the process ...I understand the definition of the advisory notice and (I think) when it should be performed, but what I'm trying to find out is if there are any particular requirements (or suggestions from brilliant minds on the forum
FYI: I started looking because we have kits in a distributors warehouse which currently hold items that we (the manufacturer) would like to pull out of the kit. From what I can tell an advisory notice is warranted here - there is no danger from the item, the test will perform to specs without the item and the item has been historically offered as a complement to the test....but we want to discontinue that practice. In order to effect the change for kits currently in the distributors warehouse, from what I can tell under 3.3 "modification of a medical device' an advisory notice would be the way to go.
Am I on the right track here?
Thanks so much!
Amanda

