⚠️ Medical Device, SaMD & In-Vitro Diagnostic Device Vigilance

Our vigilance services ensure regulatory compliance and patient safety by:

• Establishing post-market surveillance (PMS) and vigilance systems
• Detecting and reporting adverse events and incidents
• Ensuring alignment with EDE & MoHAP, as well as DHA and DOH requirements for SaMD (Software as a Medical Device), including AI-driven or AI-powered medical devices.
• Supporting root cause analysis and corrective actions, FSCA and recalls.