Gap Assessment
Find the cracks in your compliance foundation before the auditor does.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Legacy QMS Uncertainty
Unsure if your legacy QMS meets the new ISO 13485:2016 or QMSR standards?
Market Launch Unknowns
Preparing for a new market launch but unsure of the specific regulatory deltas?
Unannounced Audit Anxiety
Nervous about your first unannounced audit?
The VigilaMed Solution
Forensic Compliance Deep-Dive
We perform a forensic deep-dive into your systems, providing a brutal but necessary "Red/Amber/Green" report on exactly where you stand.
Manufacturing-First Methodology: Our gap assessment methodology identifies every compliance gap, prioritizes risks, and provides a clear roadmap to full compliance. No surprises, only clarity.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- Comprehensive Gap Report
- Risk-Prioritized Remediation Plan
- Executive Summary for Stakeholders
- Compliance Scorecard
- Remediation Timeline & Budget Estimate