IVDR Performance Evaluation: An Executive Overview
Introduction
In vitro diagnostic (IVD) devices are essential compo...
Post Market Clinical Follow: A Clinical Overview
PMCF defined as a continuous process that are updated in clinical ...
Software as Medical Device: Agile Alignment with GAMP5 Validation
The GAMP 5 framework/five-phase approach (Refer Fig) provides a st...
Adverse Event Reporting in UK – SaMD
Any event which meets these three reporting criteria is considered...
