RegulatoryIVDR—The Impact of COVID-19Sherri Fraser, PhD | February 26, 2021 Industry concerns about IVDR implementation timelines
RegulatoryIVDR: The EU’s In Vitro Diagnostic Regulation for Medical Diagnostic TestsSherri Fraser, PhD | February 5, 2021 Frequently asked questions about IVDR
Product NewsVerichem Laboratories Offers Free, CLIA Compliant, Web-Based Calibration Verification Data Reduction ServicesVerichem Laboratories | July 22, 2020 This crucial tool supports all necessary statistics required within the clinical laboratory to satisfy current CLIA and CAP requirements for the calibration verification of clinical assays
RegulatoryLegal and Regulatory Hurdles in Digital Pathology and TelepathologyKimberly Scott | February 23, 2020 Pathologists must consider licensing requirements, data privacy, consent, and quality control
RegulatoryNew Reporting Requirements for Hospital Outreach LabsKimberly Scott | March 31, 2019 Hospital outreach labs are now challenged to collect and report private payer pricing, but there may be an upside
RegulatoryFDA Suggests Complete Overhaul of IVD RegulationKimberly Scott | December 1, 2018 Proposal of a single regulatory pathway for kits and LDTs spurs controversy
RegulatorySponsoredRobots for Regulatory ComplianceTecan | December 1, 2018 How an automated workstation can create an audit-ready clinical lab
RegulatoryCLIA Compliance for Pre-Analytic, Analytic, and Post-Analytic Testing PhasesJohn A. Bilello, PhD | October 24, 2018 Regulatory requirements aim to get the right results to the right patients