Comprehensive support for medical device vigilance, including incident reporting, follow-up, and regulatory submissions.
Ensuring all device-related activities meet global and local regulatory requirements and audit standards.
Efficient intake, triage, and prioritization of device incidents to support rapid and accurate case processing.
Accurate data entry and documentation of device incidents for regulatory and quality management purposes.
Expert medical review of device incidents by qualified professionals to assess causality and risk.
Robust quality control and documentation practices to ensure audit readiness and regulatory compliance.
Seamless integration of device vigilance with pharmacovigilance databases and workflow tools.
Efficient turnaround and regular reporting to meet regulatory timelines and business needs.