What Are eIFU Services
Electronic Instructions for Use (eIFU) services are revolutionizin...
Rising Demand for Remote Patient Monitoring Devices
The healthcare landscape is rapidly evolving, driven by technologi...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermitt...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guidel...
Software as Medical Device: Agile Alignment with GAMP5 Validation
The GAMP 5 framework/five-phase approach (Refer Fig) provides a st...