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 […]
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 […]
Data Extraction and Appraisal Tables in Systematic Literature Reviews: What a Notified Body Expects to See
Author: Sarah VanVickle Chaves, Director of IVD and Scientific Writing Services, Ph.D. Molecular and Cellular Biology For medical device and in vitro diagnostic (IVD) manufacturers, identifying relevant literature is only […]
