INDUSTRIES / MEDICAL DEVICES

Keep every device test ready for review.

Connect component checks, calibration measurements, and final functional tests to the device that was tested. Give engineering and quality teams the same evidence when they review a result or a retest.

Medical instruments with displays, tubing and a handheld probe

Testing challenges

01

Identify each assembly.

Connect component checks to the final device and its configuration.

02

Keep the calibration evidence.

Retain reference readings, adjustments and the resulting verification run.

03

Review every attempt.

Give engineering and quality teams the same original and retest evidence.

WORKFLOW EXAMPLE

Review a diagnostic instrument’s fluidics module.

An illustrative bench workflow linking a reference check, module characterization, and the assembled instrument. Your team defines the procedure and acceptance criteria.

WORKFLOW EXAMPLEDIAG-0217

Fluid path in the test fixture

Fluidics modulePump · serial
Reference fixtureFlow · pressure
Functional checkResponse · limits
Keep the fluidics module’s measured response with its calibration and device identity.
  1. Check the reference

    Run a known-good reference module and retain its measured sensor response with the station record.

  2. Characterize the module

    Record pressure and flow measurements against the production module’s serial and procedure version.

  3. Review the assembled device

    Link the module to the instrument and bring its results into the final functional-test review.

ALERT & NEXT STEP · EXAMPLE

The known-good reference module failed its bench check.

Notify the responsible engineer with the reference run. Review the setup and recent device results, then have the team decide which checks to repeat before release.

Connect the next step

RESOURCES

Start with a relevant procedure.

Fluidics module characterization

Record sensor response, module identity, and reference measurements in one bench procedure.

PROCEDURE IDEA · EXAMPLE

Diagnostic instrument functional test

Bring subassembly results, instrument configuration, and final functional checks together.

PROCEDURE IDEA · EXAMPLE

ISO 13485 Test Data Requirements

Learn how to meet ISO 13485 test documentation requirements for medical devices using TofuPilot's structured data and traceability features.

PRACTICAL GUIDE
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Make it work on your hardware.

Bring one procedure and a representative set of results. We’ll help you plan the first integration.