Medical device manufacturers and other industry stakeholders are waiting for the draft harmonized Quality System Regulation from the US Food
It has become common these days to hear “We live in unprecedented times.” The medical device industry and FDA have
IVD tests have two components of accuracy – sensitivity and specificity. Just as specificity is important for serology tests (https://asell.com/regulatory-considerations-for-sars-cov-2-serology-test-developers/),
Given the considerable recent focus on serology assays for the detection of IgG and IgM antibodies to SARS-CoV-2, we wanted