QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo Medical device manufacturers and other industry stakeholders are waiting for the draft harmonized Quality System Regulation from the US Food FDA and the Device Industry: Challenges in Working Together During the SARS-CoV-2 Pandemic It has become common these days to hear “We live in unprecedented times.” The medical device industry and FDA have Regulatory and Practical Considerations for SARS-CoV-2 Direct Detection Test Developers 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/), 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
