The platform
74 modules. One platform.
Six domains covering the full medical-device manufacturing lifecycle — from incoming inspection to executive intelligence.
Quality, end to end. ISO 13485 by design.
A complete quality management suite covering incoming goods, in-process inspection, FAI, SPC, NCR/CAPA workflows, and OEM-facing customer portals. Every record is electronically signed and version-locked under 21 CFR Part 11.
- ✓First Article Inspection (FAI)
- ✓First Pass Yield (FPY) tracking
- ✓Statistical Process Control (SPC)
- ✓Device History Record (DHR)
- ✓Incoming Inspection workflow
- ✓Non-Conformance Reports (NCR)
- ✓Corrective Action (CAPA)
- ✓Customer Quality Portal
- ✓Hold & quarantine management
- ✓Quality KPI dashboards
- ✓Out-of-tolerance alerting
- ✓Root-cause analysis tooling
c5e2bd8e. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded
demonstration data — no part, person or customer here is real.
Real-time floor intelligence. No manual entry.
Live OEE direct from machine telemetry. Closed-loop scheduling that absorbs unplanned downtime in real time. In-process documentation that operators actually use because it's on the work order, not on the shared drive.
- ✓OEE — live per machine and fleet
- ✓Production scheduling (closed-loop)
- ✓In-Process Documentation (IPD)
- ✓Standard Times & variance analysis
- ✓Operator graduation & release
- ✓Work order execution tracking
- ✓Setup time tracking
- ✓Downtime root-cause coding
- ✓Shift handover briefings
- ✓Throughput vs. takt time
- ✓Cell load balancing
- ✓Live escalation routing
c5e2bd8e. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded
demonstration data — no part, person or customer here is real.
CMM data, parsed automatically.
AI-powered ingestion for Renishaw, Hexagon, and Zeiss output. The platform reads the report, extracts every feature, links it back to the part drawing tolerance, flags out-of-tolerance, and writes the result to the DHR — without an inspector touching a keyboard.
- ✓CMM result ingestion (auto)
- ✓Renishaw / Hexagon / Zeiss support
- ✓AI feature-to-tolerance mapping
- ✓Calibration management
- ✓Out-of-tolerance alerting
- ✓GD&T attribute parsing
- ✓Instrument type classification
- ✓Operator-readable PDF reports
- ✓Drift detection over lots
- ✓Auto-link to part revision
c5e2bd8e. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded
demonstration data — no part, person or customer here is real.
Training enforced at the point of work.
Operators only see operations they're trained for. Trainer/trainee workflows are built into the work order, not bolted on as a checklist. Cert expiry triggers automatic graduation review.
- ✓Training enforcement at WO start
- ✓Trainer/trainee context tracking
- ✓Operator scope by part / op
- ✓Qualio QMS bidirectional sync
- ✓Cert expiry alerts
- ✓Graduation workflow
- ✓Training gap analytics
- ✓Skills matrix by cell
- ✓Re-training trigger rules
- ✓Audit-ready training history
From shop floor to CEO. One pane of glass.
Live executive intelligence aggregated across operations, finance, supply chain, and quality. An assistant grounded in your own records: it answers using retrieval over your MESvantage data and links to the source record behind each statement. It cannot approve, sign, disposition or release anything.
- ✓CEO Intelligence Dashboard
- ✓AI Executive Agent (LLM)
- ✓Energy & sustainability intel
- ✓Machine condition monitoring
- ✓Customer-facing portals
- ✓Power BI bidirectional
- ✓Ops intelligence stream
- ✓Continuous improvement tracker
- ✓BD & pipeline intel
- ✓Competitive intel feed
- ✓Energy ECM live data
- ✓Anomaly detection (auto)
Compliance-grade foundations.
Every record signed, hashed and audit-trailed. Every action role-gated. Every customer in their own isolated deployment. The platform is the object of validation — we supply the evidence that lets your team qualify it in your environment.
- ✓Mobile PWA (install-ready)
- ✓Digital factory floor signage
- ✓Audit trail against 21 CFR Part 11 §11.10
- ✓Electronic signatures against Part 11 Subpart C
- ✓Role-based access control
- ✓Microsoft Entra SSO
- ✓Dedicated deployment per customer
- ✓Backups with tested restores — last test date published
- ✓ERP integration (M1/SAP/Plex)
- ✓Power BI bidirectional
- ✓OneDrive document linking
- ✓Infrastructure provisioned from code
How we evidence Part 11, rather than illustrate it
Audit trail and electronic signature controls are implemented against 21 CFR Part 11 §11.10, §11.50 and §11.70. We publish the control map — each control, the mechanism that implements it, and the evidence artefact that demonstrates it — rather than a picture of a record. Our current control matrix, including open items, is available for review under NDA.
See the compliance detailReady to see the full platform?
A 30-minute session walks through every domain. Bring us the hardest part you make and we will show you that part's life in MESvantage.
Book a DemoAbout the interface images on this page. They are screenshots of MESvantage running against a demonstration dataset — the real application, not illustrations of it. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded demonstration data, so no part, person or customer on this page is real. Each caption records the route, the build it was captured from, and the date.