Advisory Notices - What is the Requirement in ISO 13485

G

gfux01

#1
Hello all,

I'm just making a gap analysis from our current Management system TS16949 to ISO 13485 and i'm struggling a little bit with the word advisory notice.

Can somebody explain me what the standard understands under advisory notice as Point 8.5.1 states 'The Organization shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time'??

Thank's for your help
:thanx:
 
Elsmar Forum Sponsor

Le Chiffre

Quite Involved in Discussions
#2
Re: Advisory notices

Are you also considering Canadian Medical Device Conformity Assessment System (CMDCAS)? The federal Medical Device Regulations has more on this subject (sections 58 - 61) as well as a Health Canada guidance document on "Mandatory and Voluntary Problem Reporting for Medical Devices".

If your focus is FDA, there are some similar documents on its website.
 
G

gfux01

#5
Thank you very much for your comments!

As we are only supply parts to the Medical Industry, meaning our name is not on the product, we don't consider CMDCAS.

The definition of advisory notes also refers always to medical devices. For my understanding we don't produce medical devices only parts for medical devices as there is no exclusion for this point, has someone any ideas how to cover this point for my purposes??
 

Ajit Basrur

Staff member
Admin
#6
Hi gfux01,

Based on your response, I think your organisation is an injection molding company which makes parts and give to the customer, who ultimately make up a medical devices. Am I right ?

In this scenario, the extent of advisory notices becomes reduced but you can not claim an exclusion.

The advisory notices basically provide supplementary information about the device or specify actions that should be taken. Advisory notices include the following:

discuss the use of medical devices
discuss the modification of medical devices
discuss the destruction of medical devices, and
discuss the return of medical devices

So if your customer has to do the Advisory Notices, he will take the help of your organisation.
 
G

gfux01

#7
Hello Qualityalways,

your are right,

can you specify this reduction a little bit more detailed this would be very helpful. What are the key points of this system I have to cover at least?

Would you suggest to use the vigilance system as a guideline?

Regards,
 
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