ISO 13485 - Advisory Notices - Regulations - Quality Manual

L

lruiz

#11
Need a sample Advisory Notice procedure

Hi Bridget Could you please post a sample Advisory Notice Procedure. I was able to view the form but not the procedure.

thanks,
LR
 
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L

lruiz

#12
Could you post or send me a sample of your Advisory Notice procedure? The form you posted helped me lots, but I'd like some ideas for the procedure.

Thanks,
Lucy
 
C

Chan J

#13
Cathy said:
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.
I'm facing some problems creating a procedure for issueing out advisory notices.Will anyone care to share a standard procedure on how to write an procedure notice? Or is ther a form for advisory notices?Thank you. I understand that it's the responsibility of the Legal manufacturer to issue out the advisory notice to the suppliers should there be device changes, recall or destruction. Let's say if this supplier, (supplier X) subcontracts the product out to another party supplier (Y), shd they themself (supplier X) have their own advisory notice to follow or ours (the Legal manufacturer) to follow?Should they (supplier X) have their own vigilence system to follow and control their own suppliers or shd they follow the Legal manufacturer's?Thanks
 
T

trending

#14
Hi,
This discussion thread seems to be quite old but I'm going to start it up again!
I need to produce an Advisory Notice procedure in order to comply with ISO 13485, 8.5.1. There's a lot of information out there regarding Vigilance Reporting where advisory notices are mentioned but what I would really like is an idea of how to write such a procedure.
Does anyone have examples of a European specific Advisory Notice procedure that has passed auditor scrutiny that they dont mind sharing?!
Thank you very much :)
 
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