FDA-ready production machines with traceability
built into the software — not bolted on after.
Recipe management, audit trails, and process validation on every machine. Scaling from manual bench assembly to automated production.
Talk to an EngineerPain Points We Solve
FDA Validation & Traceability
Every FactoryRobot logs every cycle with full parameter data. Recipe management with audit trails. Process validation evidence generated automatically.
Manual to Automated
Your benchtop process works but doesn't scale. We engineer the automated version with the same process controls your quality team requires.
Recipe Management
Locked parameters, operator authentication, version history. Every run traceable to a specific recipe revision.
Products for Medical Device Manufacturing
Custom Work Cells
ACF bonding, pick-and-place, dispensing, and assembly with full traceability. Web HMI, SECS/GEM, process data logging.
Learn more →AI Inspection
Camera monitoring with anomaly detection on high-value assemblies. FDA 21 CFR Part 11 audit trail support.
Learn more →Amada Traceability
Drop-in upgrade for Amada hotbar systems. Process data collection and parameter control for compliance visibility.
Medical device customers