Regulations

MDCG guidance documents help interpret classification rules for EU MDR and IVDR

Dr. Steffini Stalos discusses common business and regulatory challenges and provides advice to achieving compliance

It's the first evidence-based analysis of how new proposed regulation of LDTs would affect health care costs

Industry concerns about IVDR implementation timelines

Frequently asked questions about IVDR

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

Pathologists must consider licensing requirements, data privacy, consent, and quality control

Hospital outreach labs are now challenged to collect and report private payer pricing, but there may be an upside

Proposal of a single regulatory pathway for kits and LDTs spurs controversy

How an automated workstation can create an audit-ready clinical lab