724 devices · GMDN 44082
Clinical laboratory information system (LIS) application software automates and integrates the workflow of lab testing, from sample tracking and test ordering to results reporting and data analysis. It ensures accurate record-keeping, reduces manual errors, and enables seamless communication between labs, clinicians, and patients by centralizing test data and workflows in real time.
These systems are typically regulated as software-as-a-medical-device (SaMD) and may require compliance with standards like ISO 13485 or FDA’s software validation guidelines. They are often supplied as standalone software or integrated into larger hospital or lab IT ecosystems, depending on the facility’s existing infrastructure and needs.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.