Hi QA Tech - don't know if you have found an anwser to your advisory notice question. Here's my input
Advisory notices can be issued from the country's competent authorities or by the manufacturer to the competent authority.
When you (as the manufacturer) issue an advisory notices you need to include detailed information on the following:
1. the type of incident (or potential incident)
2. whether any medical device has been involved that the manufacturer is responsible for
3. whether the incident was caused, wholly or partly, by the medical device
4. if there is any short comings in the information supplier with the product.
To see exmaples of advisory notices check out FDA website or try this link though it is for UK competent authority.
http://www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwMDASafetyWarnings?Open&count=9999
One thing I will say about the transition from manufacturing to manufacturing medical devices is you need to be very careful in understanding the medical device vigilance. This is built into ISO13485:2003 to some extent but consult the FDA regulations on this area.