I can highly recommend conferences sponsored by the Food and Drug Law Institute. This organization is geared toward the lawyers that practice FDA law. The regulatory profession does not exist without FDA ...

If something happened to an end user and you learned about it, then you will initiate a complaint under 820.198. The complaint triggers an investigation to determine if it is reportable as a Medical ...

This message was posted by a user wishing to remain anonymous Hello Anon As long as the company remains in business, there is responsibility for complaint handling, incident reporting, and postmarket ...

This message was posted by a user wishing to remain anonymous Standard doesn't say which departments have to approve. Manufacturer has to define which approvers should be required. Agree independence ...

This message was posted by a user wishing to remain anonymous Anon, is it your customer modifying a device they bought? Is it a distributor? Is it a company authorized by you to perform service? How ...

This message was posted by a user wishing to remain anonymous Hi Anon If you have a huge catalog then you already have many UDIs and many GUDID entries. FURLS is a little more flexible about grouping ...