Mock Audits
Pass your FDA inspection or Notified Body audit with zero major findings.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Fear of Findings
Uncertainty about what auditors will find, leading to last-minute panic and rushed fixes.
Unknown Gaps
Hidden compliance issues that only surface during the actual audit, causing delays and rejections.
Inadequate Preparation
Staff unprepared for audit questions, leading to inconsistent responses and documentation gaps.
The VigilaMed Solution
Comprehensive Audit Readiness Program
We conduct rigorous mock audits that mirror real FDA and Notified Body inspections. Identify and fix issues before they become findings.
Manufacturing-First Methodology: Our audit simulation includes document review, facility walkthroughs, and staff interviews. We prepare your team for every scenario.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- Mock Audit Report (detailed findings)
- Remediation Action Plan
- Staff Training & Interview Prep
- Documentation Gap Analysis
- Pre-Audit Checklist & Timeline