How to Classify Medical and Diagnostic Devices for European Markets
Raeesa Gupte, PhD | Nov 22, 2021
MDCG guidance documents help interpret classification rules for EU MDR and IVDR
Compliance
Clinical Labs in the Spotlight: Compliance Is More Important Than Ever
Kimberly Scott | Nov 04, 2021
Dr. Steffini Stalos discusses common business and regulatory challenges and provides advice to achieving compliance
IVDR—The Impact of COVID-19
Sherri Fraser, PhD | Feb 26, 2021
Industry concerns about IVDR implementation timelines
IVDR: The EU’s In Vitro Diagnostic Regulation for Medical Diagnostic Tests
Sherri Fraser, PhD | Feb 05, 2021
Frequently asked questions about IVDR
Verichem Laboratories Offers Multi-Analyte, Bio-Synthetic, NIST Traceable, Urine Chemistries Standards Kit
Verichem Laboratories | Jun 25, 2020
The availability of the kit is certain to address the needs of a wide variety of clinical laboratory professionals
Robots for Regulatory Compliance
Tecan | Dec 01, 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 | Oct 24, 2018
Regulatory requirements aim to get the right results to the right patients