Quality caught at the point of production —
not discovered during the audit.
Qontiv is a cloud manufacturing execution system with native quality modules for regulated manufacturers. ISO 13485 and FDA QMSR for medical device. IATF 16949 for automotive. AS9100 for aerospace. One system — not a QMS bolted to an MES.
In design-partner phase · Structured 4-week pilot · No long-term commitment required
Medical Device
ISO 13485 + FDA QMSR
QMSR has been in effect since February 2, 2026. FDA is using the new inspection process today.
See medical device →Automotive
IATF 16949 (Rules 6th Ed.)
APQP, PFMEA, LPA, supplier corrective action — native to the MES.
See automotive →Aerospace
AS9100 Rev D
Production records, configuration management, e-signatures — captured at the work order, not assembled before the audit.
See aerospace →Built for manufacturers
Everything your floor needs in one system
From machine signal to shift report — Qontiv captures what happens on your floor automatically, so your team spends time improving yield instead of entering data.
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Real-time OEE
Track Availability, Performance, and Quality automatically from machine signals. No manual data entry.
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Electronic Work Instructions
Step-by-step operator guidance with measurement inputs, e-signatures, and photo evidence.
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Statistical Process Control
Built-in SPC charts with Western Electric rule detection. Catch process drift before it becomes scrap.
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Edge Machine Connectivity
Connect via OPC-UA and MQTT. First machine online in under 2 hours — no middleware required.
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Production Scheduling
Drag-and-drop Gantt scheduler with equipment utilization visibility and constraint-aware sequencing.
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AI Copilot
Ask questions about your production data in plain language. Anomaly detection surfaces issues proactively.
OEE & Analytics
Know your OEE shift by shift, not month by month
Qontiv connects to your machines and automatically calculates Availability, Performance, and Quality from real signals — not manual log entries. Supervisors see live OEE on the floor; managers see shift trends in the dashboard.
- Automatic downtime event capture with reason codes
- Shift-by-shift OEE trends and Pareto analysis
- Six Big Losses breakdown per machine
- OEE comparison across equipment, shifts, and products
OEE dashboard screenshot
Join the founding cohort
Qontiv is in design-partner phase with a small group of manufacturers shaping the product alongside us. Become a founding customer and lock in pricing and feature direction.
Request a DemoReady to see Qontiv in your environment?
A 30-minute walkthrough with your equipment and your data.