Validation Guidance for Medical Laboratories IBMS LabMed MHRA UKAS.pdf
Validation Guidance for Medical Laboratories provides practical guidance for validating and verifying in vitro diagnostic devices in line with ISO 15189 requirements. It covers manufacturer claim verification, off-label use, laboratory-developed tests, RUO reagents and emerging technologies, with a risk-based framework, practical workflow and real-world case studies to support safe, reliable and fit-for-purpose testing
A presentation will be led by IBMS Vice President Debra Padgett, Clinical Pathology Lead and Lead Healthcare Scientist, Northumbria Healthcare NHS Foundation Trust.
Jonathan Boxshall, Pathology Quality Manager and Deputy Clinical Pathology Lead, and Richard Hardy, Blood Science Service Manager, give a guided tour of Northumbria pathology.
