1. Is there a rework procedure in the tool kit? I did not see it in there and I believe it is an ISO requirement for clause 8.3.4. Thank you.
2. I have a question about the clinical evaluation requirement. What exactly is needed for media manufacturer class 1 medical device?
In looking at the documents in the toolkit it I am not sure if it applies.
3. Also when is a CE mark required? How do I apply for a UDI # since we don’t currently have one?