Materiovigilance Support – Global Reporting, Complaint Handling & Investigations for Catheters and Interventional Medical Devices​ ​

Case generation, review, and timely submission of MDRs to the FDA​

Identification of reportable events from literature and logging them appropriately​

Triage and logging of complaints received via forms, emails, or telephone transcripts​

Identification and logging of reportable events from PMCF studies​

Execution of complaint investigations and lab evaluations​

Coordination with engineering and cross-functional stakeholders to identify and analyze information needed for root cause determination and CAPA​

Event coding aligned with IMDRF adverse event and device problem codes​

Despite limited resources, Celegence successfully reduced the active case backlog from 500 to under 100.

Improving timelines from working cases due in 2 days to managing submissions with a 20+ day window​

Drastically reducing late submissions and improving on-time delivery​

Rapid adaptation to client-specific software and platforms​

Achieving consistently low FDA rejection rates while covering all global regions with timely notifications​