Medical Device Manufacturing Software

FDA-compliant manufacturing ERP for medical devices. DHR management, validation protocols, CAPA tracking, and full audit trails.

Frequently Asked Questions

What ERP is best for medical device manufacturers?

MonitorZ provides FDA 21 CFR Part 11 compliant manufacturing ERP for medical device companies. Features include device history record (DHR) management, validation protocols, CAPA tracking, and complete audit trails.

Is MonitorZ FDA 21 CFR Part 11 compliant?

Yes. MonitorZ includes electronic signature support, complete audit trails, user access controls, and device history record management required for FDA 21 CFR Part 11 compliance in medical device manufacturing.

Your Production Line is Tangled — and You Can’t See the Knots

MonitorZ is manufacturing ERP software reinvented around Object Velocity. Untangle your factory floor and build products faster. One real line gained 133% throughput in 120 days — same machines, same crew, sequence untangled.

The Problem: Hidden Sequence Waste

Every factory has capacity it cannot see. Objects wait, cross paths, double back, and starve downstream stations. The constraint is not your machines — it is the tangled sequence between them. No ERP, no spreadsheet, and no whiteboard meeting reveals these invisible knots.

The Fix: Object Velocity

MonitorZ sees every object on your floor in real time — lots, WIP, tools, machines, finished units. It untangles the production sequence by placing each object at the right station, in the right order, at the right time, then pacing the line so nothing waits and nothing crosses its own track.

How It Works

  1. Scan & Connect — OPC UA machine data + smartphone scanning, no rip-and-replace
  2. See the Knots — Real-time object map reveals where sequence tangles form
  3. Untangle — AI-driven sequencing places objects in optimal flow order
  4. Pace the Line — Continuous velocity monitoring keeps throughput climbing

Results

Manufacturing Modules