PRISMA-Compliant Literature Reviews: What “PRISMA-Compliant” Actually Means for Your CER or PER
Author: Sarah Chavez, Director of IVD and Scientific Writing Services For medical device and IVD manufacturers, literature reviews are much more than background research. They are an important component of […]
Liquid Biopsy and Circulating Tumor DNA Assays: Regulatory Evidence Expectations Under IVDR and FDA
Author: Sarah Chavez, Director of IVD and Scientific Writing Services Regulatory evidence considerations for ctDNA and liquid-biopsy IVD development in the United States and European Union Liquid biopsy is reshaping […]
Analytical Performance Report vs. Clinical Performance Report: What Each Demonstrates Under IVDR
Analytical Performance Report (APR): Can the device reliably detect or measure the analyte? Clinical Performance Report (CPR): Do the device results meaningfully correlate with the intended clinical condition or physiological/pathological […]
