IVDR—The Impact of COVID-19
Sherri Fraser, PhD | February 26, 2021
Industry concerns about IVDR implementation timelines
Regulations
IVDR: The EU’s In Vitro Diagnostic Regulation for Medical Diagnostic Tests
Sherri Fraser, PhD | February 5, 2021
Frequently asked questions about IVDR
Verichem Laboratories Offers Free, CLIA Compliant, Web-Based Calibration Verification Data Reduction Services
Verichem 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
Legal and Regulatory Hurdles in Digital Pathology and Telepathology
Kimberly Scott | February 23, 2020
Pathologists must consider licensing requirements, data privacy, consent, and quality control
New Reporting Requirements for Hospital Outreach Labs
Kimberly Scott | March 31, 2019
Hospital outreach labs are now challenged to collect and report private payer pricing, but there may be an upside
FDA Suggests Complete Overhaul of IVD Regulation
Kimberly Scott | December 1, 2018
Proposal of a single regulatory pathway for kits and LDTs spurs controversy
Robots for Regulatory Compliance
Tecan | December 1, 2018
How an automated workstation can create an audit-ready clinical lab
CLIA Compliance for Pre-Analytic, Analytic, and Post-Analytic Testing Phases
John A. Bilello, PhD | October 24, 2018
Regulatory requirements aim to get the right results to the right patients