A reversed seal or a missing O-ring is a recall, not a rework.
A reversed seal or a missing O-ring is a recall, not a rework. Bond-line gaps are invisible once the device is closed, particulate is found at final inspection if it is found at all, and one unit's record takes days to assemble for an auditor.
UDI, lot codes and labels read on every unit, so an unreadable label doesn't halt a shipment later.
Camera at receiving and kitting
No shipment halted by an unreadable label
Bond-line coverage checked at the station, while a gap can still be reworked.
In-line camera at the bonding station
Gaps caught while they can be reworked
Every seal, O-ring and component checked for presence and orientation before the device is closed.
Fixed camera before the device is closed
Every component verified before closure
Images and results stored against each serial, ready when an auditor asks for a single unit.
Loopr Inspect Intelligence
Single-unit records ready for ISO 13485 and 21 CFR Part 11
Per-unit inspection evidence ready for ISO 13485 and 21 CFR Part 11 audits.
Loopr is hardware-agnostic and runs on the equipment already on your line. Tell us what you inspect and we'll validate impact in four weeks.