Crisis Remediation
Transform FDA 483s and Warning Letters into compliance excellence.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
FDA 483 Response
Urgent need to respond to FDA observations within 15 days, with limited time to implement effective fixes.
Root Cause Unknown
Surface-level fixes that don't address underlying systemic issues, leading to repeat findings.
Warning Letter Risk
Escalation to Warning Letter status threatens market access and regulatory standing.
The VigilaMed Solution
Six Sigma CAPA Methodology
We use proven Six Sigma methodologies to identify root causes and implement permanent solutions. No band-aids—only systemic fixes.
Manufacturing-First Methodology: Our structured approach ensures FDA-acceptable responses that demonstrate genuine improvement, not just compliance theater.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- FDA 483 Response Document
- Root Cause Analysis Report
- CAPA Implementation Plan
- Effectiveness Verification Protocol
- Follow-up Audit Preparation