Medical Device Service Support

Device Vigilance Reporting

Comprehensive support for medical device vigilance, including incident reporting, follow-up, and regulatory submissions.

Regulatory Compliance

Ensuring all device-related activities meet global and local regulatory requirements and audit standards.

Incident Intake & Triage

Efficient intake, triage, and prioritization of device incidents to support rapid and accurate case processing.

Data Entry & Documentation

Accurate data entry and documentation of device incidents for regulatory and quality management purposes.

Medical Review

Expert medical review of device incidents by qualified professionals to assess causality and risk.

Quality Assurance

Robust quality control and documentation practices to ensure audit readiness and regulatory compliance.

Integration with PV Systems

Seamless integration of device vigilance with pharmacovigilance databases and workflow tools.

Timely Delivery

Efficient turnaround and regular reporting to meet regulatory timelines and business needs.