Quality & manufacturing

Quality you can trace, test and inspect.

The proof behind each machine should be as clear as the result it delivers.

“We test everything” is easy to say. We make the work visible: named checks before assembly, a recorded aging routine before shipping, and in-house equipment you can ask to see in action. Review a sample before you commit to a run.

QC station / handpiece and system check

100

%

Mainboards checked before assembly

Every board is tested before it goes into a unit.

30

h+

Bench aging before dispatch

Time under load belongs on our bench, not your clinic floor.

0.1

%

Field defect rate on mature lines

Around one in a thousand on established models.

4

In-house test rigs to demonstrate

Climate, corrosion, vibration and impact checks.

A record follows every build

Eight checkpoints between the component bin and a sealed box.

Quality is not one final glance at the end of a line. It is a sequence of controls, with the unit and its batch tied back to the process that produced it.

BUILD RECORD

Every stage has a job to do before the next one starts.

  1. 01
    Confirm

    Build approved

    The order, target specification and production plan are confirmed before materials are purchased.

  2. 02
    Source

    Named parts purchased

    Components are ordered through stable, named suppliers for a repeatable build.

  3. 03
    CONTROL

    Incoming inspection

    Appearance and weight sampling, a 30-minute plug-in check, and screen light-up inspection happen before parts enter stock.

  4. 04
    Prepare

    Line pull checked again

    Materials are counted and inspected as they move from stock into production.

  5. 05
    CONTROL

    Every mainboard tested

    No sampled board batches. Each board is tested before it is installed in a machine.

  6. 06
    Assemble

    Handle built and verified

    The treatment-side component is assembled and checked independently before final integration.

  7. 07
    CONTROL

    Wiring and switches secured

    Connections are soldered and prepared for vibration, transport and daily use.

  8. 08
    CONTROL

    QC, aging, then seal

    Finished-product inspection and load aging take place before the unit is packed and released.

A record follows every build

Eight checkpoints between the component bin and a sealed box.

Quality is not one final glance at the end of a line. It is a sequence of controls, with the unit and its batch tied back to the process that produced it.

  1. 01Confirm

    Build approved

    Order, specification and production plan confirmed before any material is purchased.

  2. 02Source

    Named parts purchased

    Components ordered through stable, named suppliers for a repeatable build.

  3. 03Control

    Incoming inspection

    Appearance and weight sampling, a 30-minute plug-in check and screen light-up before parts enter stock.

  4. 04Prepare

    Line pull checked again

    Materials counted and inspected as they move from stock into production.

  5. 05Control

    Every mainboard tested

    No batch sampling. Every board passes a functional test before it is installed.

  6. 06Assemble

    Handle built and verified

    The treatment-side component is assembled and checked before final integration.

  7. 07Control

    Wiring and switches secured

    Connections soldered and secured for vibration, transport and daily use.

  8. 08Control

    QC, aging, then seal

    Finished-product inspection and load aging before the unit is packed and released.

Control stages are hard gates. A unit does not move to the next step until it passes.
A record follows every build

Eight checkpoints between the component bin and a sealed box.

Quality is not one final glance at the end of a line. It is a sequence of controls, with the unit and its batch tied back to the process that produced it.

Kalynn production line: eight checkpoints from component bin to sealed box
  1. 01Build approved
  2. 02Named parts purchased
  3. 03Incoming inspectionControl
  4. 04Line pull checked again
  5. 05Every mainboard testedControl
  6. 06Handle built and verified
  7. 07Wiring and switches securedControl
  8. 08QC, aging, then sealControl
Control stages are hard gates. A unit does not move to the next step until it passes.
We try to expose the weak point here

Time, movement and impact all happen before shipment.

The failure that would otherwise arrive after months of treatment sessions is what this routine is designed to reveal. New models or changed components receive additional aging before release.

TIME
0min

Load aging, per function

A four-function machine runs two full hours under functional load.

0h+

Finished-unit aging

Each unit stays on the aging bench before it can ship.

0h

Extra change control

Additional aging for a new model, supplier change or component swap.

MOVEMENT
0min

Vibration-tested before packing

Every unit runs on the vibration table, then we re-inspect the wiring and solder joints.

IMPACT
2 + 3

Packaging drop test

Two corners and three edges, with height set to package weight.

Test it in front of you

Equipment we can put to work, not just list on a certificate.

Owning the test equipment means a claim can be demonstrated while you are here, rather than left as a document you have to take on faith.

Constant temperature and humidity test chamber
01 / Climate

Constant temperature & humidity chamber

Precision salt-spray corrosion tester
02 / Corrosion

Precision salt-spray tester

Transport vibration simulator
03 / Transit

Transport-vibration simulator

Dual-arm drop tester
04 / Impact

Dual-arm drop tester

Ask what applies to your device, market and shipping setup. We will show you the relevant check.

The components have a name

Materials and documents ready for a real buyer's questions.

A device is only as auditable as the information behind it. We identify the core materials and carry the approvals your market may require.

01

ABS housings and tin-plated copper internal wiring.

02

National-standard certified power cords and 18650 lithium cells.

03

Medical-grade stainless-steel handles at the treatment point.

04

Component sourcing can be reviewed against the applicable product specification.

ISO 13485

SGS checked

CE

FDA

RoHS

MSDS

FCC

Material inspection before production

Q

Make the decision with evidence

Inspect the unit before you put your name behind it.

Ask for production and packing photos, a sample inspection-report template, or a unit for third-party testing. We will help define what should be checked for your device and destination market.