K
Hi all,
Our product is only software, classified as class II device with regards to CMDR and FDA and class I according to MDD.
I have written a procedure for recall and advisory notice, but now that I come to the recall section, I am wondering if this is necessary... I don't see a situation where I would absolutely need a recall instead of an advisory notice (with confirmation)?
Any thoughts?
Thanks
Our product is only software, classified as class II device with regards to CMDR and FDA and class I according to MDD.
I have written a procedure for recall and advisory notice, but now that I come to the recall section, I am wondering if this is necessary... I don't see a situation where I would absolutely need a recall instead of an advisory notice (with confirmation)?

Any thoughts?
Thanks