The manufacturing intelligence
platform for medical device CDMOs.
Connect your ERP, your quality system, your CMMs and your machines into one validated platform. Built for regulated manufacturing. Live on your floor in 90 days.
One platform, every system on your floor.
MESvantage sits at the centre of your manufacturing stack — ingesting data from ERP, quality, machines and metrology, and turning it into validated records, real-time intelligence, and customer-ready outputs.
Every customer runs in a fully isolated deployment. No shared compute, no shared databases, no cross-customer data — by design and by audit requirement.
The gap nobody else fills.
Purpose-built for CDMOs
Not a generic MES retrofitted to medical. Every workflow — DHR, FAI, CMM, OEE, NCR, lot release — was designed for regulated contract manufacturing from day one.
Validation transferable
IQ/OQ/PQ baseline already passed in a live regulated environment. Validation evidence transfers with the platform. Skip the 12-month validation programme.
Production-grade
Stress-tested at scale, 24/7, under FDA scrutiny. Every feature has run on a real production floor — not a lab, not a pilot, not a demo environment.
Real-time intelligence. Without the Excel.
See your shop floor the way your CEO wants to see it: live, drillable, audit-ready.
Operations Dashboard
Live · Sample data · Updated 14:06
Sample data shown. Each MESvantage deployment runs in its own isolated environment.
Every machine, every shift, every alert — predictive.
Live ingestion from OPC-UA, MTConnect and Modbus. ML models trained per machine class predict thermal drift, dimensional risk, and tool wear before they break a part — not after.
- ▸Real-time OEE per cell, work centre, and fleet
- ▸Thermal-drift prediction with 24-hour horizon
- ▸Auto-generated maintenance work orders
- ▸Closed-loop feedback to scheduling
- ▸Edge ML — no cloud round-trip required
- Tool change overrun on Wed — operator Smith K. flagged thermal drift; 47min unscheduled stop.
- PT-2049-B setup time averaging 28% above Standard Time. Linked NCR NCR-1147 still open.
- Operator coverage — 3 shifts ran short by 1 trained operator (Qualio cert gap).
Ask the question. Skip the dashboard.
A purpose-built LLM trained on your shop floor. It speaks DHR, FAI, NCR, OEE and ERP — and it cites every source. Auditors love it. Operators ask it everything.
- ▸Trained on your data, never co-mingled with another customer
- ▸Cites source records for every claim — audit-defensible
- ▸Drafts work orders, NCRs and CAPAs from natural-language requests
- ▸Available to every authorised role — operator to CEO
- ▸Runs in your isolated environment — your data never leaves
Every part. Every operation. Every signature.
Trace a single serial number from raw stock to OEM dispatch in two clicks. Audit-ready out of the box.
50+ modules across 6 domains.
From incoming inspection to executive intelligence — everything a regulated CDMO needs in one validated platform.
Quality
FAI · FPY · SPC · DHR · NCR · CAPA · Incoming Inspection · Customer Quality Portal
Production
OEE · Scheduling · In-Process Documentation · Standard Times · Operator Graduation
Metrology
CMM integration with AI-powered parsing for Renishaw, Hexagon, and Zeiss
Training
Training enforcement, trainer/trainee context, operator-scoped access controls
Intelligence
CEO Dashboard · AI Executive Assistant · Energy Intelligence · Machine Intel
Platform
Mobile PWA · Digital Signage · Audit Trail · Electronic Signatures · RBAC · SSO
Ready to see it on your floor?
A 30-minute demo shows the full platform running against real manufacturing data, mapped to your stack.
Book a Demo