Hi,
Just had a third party audit for FDA, 13485, and the Canadian Medical Device Regulations. One of the audit findings addressed the lack of "a technical and geographic scope" in our Quality Manual. I have searched 21 CFR, 13485, and CMDR, but cannot find a reference to that particular item. Any ideas?

Just had a third party audit for FDA, 13485, and the Canadian Medical Device Regulations. One of the audit findings addressed the lack of "a technical and geographic scope" in our Quality Manual. I have searched 21 CFR, 13485, and CMDR, but cannot find a reference to that particular item. Any ideas?
