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.
The session will take a broader look at IVD regulation in the UK to show how current regulatory approaches are designed to support access to safe products for patient benefit.
