Special Machine · 2023

Cleanroom Assembly Station

Medical Device Manufacturer

Assembly of micro-components for a Class II medical device required ISO 7 cleanroom compliance, sub-0.1mm tolerance, and full traceability per FDA 21 CFR Part 11.

Designed a UR10e collaborative robot station with force-torque sensing, integrated barcode traceability, and a custom cleanroom-grade enclosure.

Every mechanical component was rated for cleanroom compatibility (316L SS, anodized aluminum). Force-torque feedback enabled compliant insertion without damaging fragile components. A custom MES interface logged every operation with timestamp and operator ID.

0.08mm assembly accuracy
Full FDA 21 CFR Part 11 compliance
100% electronic traceability
Validated in 6 weeks
← Back to Projects
Start a similar project →