I just heard about an ISO/CD 14969:200X which is supposed to be a draft of the guidelines to implement ISO 14385:2003.

could any one tell me where i could get a copy of this draft please.

thanks per advance

V

Vincnet:

Its US$25 @ AAMI.org
Here is the link to search for the document:
http://www.aami.org/applications/search/

Cheers Al
couldn't find itr the first time;
nedd a coffee to open my eyes and i'll go back hunting for it.

V

Just type 14969 in the "or Enter Keywords:" field and it should find it.

Does anyone have a template that I can use to put together an internal audit program for a device manufacturing company.
Thanks,
bige@lab