Complaint Handling & Adverse Events
Turn customer complaints into quality improvements, not warning letters.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Aging Complaint Backlog
Backlog of open complaints that are aging past the 30-day window?
Reportability Uncertainty
Unsure if a specific failure requires an MDR/Vigilance report to authorities?
Recurring Failures
Inconsistent root cause analysis (RCA) leading to recurring failures?
The VigilaMed Solution
Triage-Based Complaint Handling
We deploy a triage-based complaint handling process that separates non-reportable noise from reportable signals, ensuring you report on time, every time.
Manufacturing-First Methodology: Our systematic approach ensures timely MDR/Vigilance reporting while driving meaningful quality improvements through proper root cause analysis.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- Complaint Handling SOP
- MDR/Vigilance Decision Tree
- eMDR Submission Support
- Root Cause Analysis Framework
- Complaint Trend Dashboard