Case Study — Medical Devices
From paper DHRs to audit-ready in 9 months
A Class II device manufacturer replaced paper device history records and a legacy MRP system with integrated ERP + QMS — and passed their next FDA audit with zero findings.
0
FDA audit findings post go-live
75%
Faster DHR assembly
9 mo
Full implementation timeline
“For the first time, quality and production are looking at the same record. Audit prep went from three weeks to an afternoon.”
VP of Quality, Meridian Medical Components
The Engagement
About Meridian Medical Components
A Class II device manufacturer replaced paper device history records and a legacy MRP system with integrated ERP + QMS — and passed their next FDA audit with zero findings.
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