B
Please, I'm a little bit lost about what is the information included in a COA of one IVD medical device. One Korean customer request to me more information to include in our coagulation COA, like CV value, deviation and coeficient of correaltion, precision, accuaracy, linearity and check with another company's controls/ calibrators at least 3 lots diferents.anyone knows if there is any standard or guide about COA?
Thanks a lot