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hi, i've spent the last hour searching the forum db for some 13485 sample document... so far i'm only got this existing discussion thread: Please review my Quality Manual , but i am looking for more example/sample/template. So i have a better idea what exactly i need to put in the huge documentation.
we are trying to get approve by Health Canada and so we are filling the 13485 Class II... we already got the ISO13485:2003 pdf and read through it, and now about to make the documentation. Just need some sample to follow through side by side.
Some links would be appreciated.
Thanks
we are trying to get approve by Health Canada and so we are filling the 13485 Class II... we already got the ISO13485:2003 pdf and read through it, and now about to make the documentation. Just need some sample to follow through side by side.
Some links would be appreciated.
Thanks
