01Aerospace02Heavy Engineering03Home Improvements04Medical Devices05Battery & Semiconductor06Data Centers & Control Systems
Industries/Medical Devices
06
Devices & life sciences
Medical Devices

Every component present, oriented and on record before the device closes.

A reversed seal or a missing O-ring is a recall, not a rework.

Days → min
Per-unit inspection evidence ready for ISO 13485 and 21 CFR Part 11 audits.
Escapes −20–30%
Reversed or missing components
Rework −10–20%
Bond-line gaps hidden after assembly
The problem

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.

What Loopr changes
01
Escapes −20–30%
Reversed or missing components
02
Rework −10–20%
Bond-line gaps hidden after assembly
03
Scrap −15–60%
Cleanroom particulate found too late

What we inspect in medical devices

Runs on the cameras, tablets and microscopes already on your line.
01
Device assemblies
02
Seals & O-rings
03
Bonded assemblies
04
Labels, UDI & lot codes
01
01
Incoming parts inspection

Label, UDI & lot code

Receiving & kitting

UDI, lot codes and labels read on every unit, so an unreadable label doesn't halt a shipment later.

What it checks
UDI
Lot codes
Label legibility
Setup

Camera at receiving and kitting

Result

No shipment halted by an unreadable label

02
02
Inline inspection

Bent tip & weld micro inspection

Surgical tools

Each tool tip checked under the microscope for bends and incomplete welds, with an image saved for every part.

What it checks
Bent tips
Incomplete welds
Setup

Camera on the existing inspection microscope

Result

Throughput up from 15 to 60 parts per hour

03
03
Final inspection

Component presence & orientation

Pre-closure check

Every seal, O-ring and component checked for presence and orientation before the device is closed.

What it checks
Missing seals & O-rings
Reversed components
Setup

Fixed camera before the device is closed

Result

Every component verified before closure

04
04
Inventory & MRO

Per-unit inspection evidence

Audit-ready records

Images and results stored against each serial, ready when an auditor asks for a single unit.

What it checks
Per-serial images
Inspection results
Setup

Loopr Inspect Intelligence

Result

Single-unit records ready for ISO 13485 and 21 CFR Part 11

Proof point
Days → min
Audit readiness · Loopr deployment

Per-unit inspection evidence ready for ISO 13485 and 21 CFR Part 11 audits.

Other industries

Begin your Quality Intelligence journey

Put Vision AI on your device line.

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.