SDN Members don't see this ad. (About Ads) Hello, I would like to get more info about a company named Oridion. The company is originally Israeli, how could I know they verified by the US Public Health Service? They are working on Patient safety monitoring, and in their contact page it says they make capnography in the US and Germany. Their "Quality Policy" says they got "accordance" with the "USA Code of Federal Regulations (CFR)21CRF82, Quality System Requirements (QSR) for Medical Devices - The American Food and Drug Administration (FDA)" How can I know? because I know that the FDA is part of the PHS, but what about this CFR / QSR?