Test Infrastructure And Measurement Engagements For Medical Devices

Discover The Projects

Test infrastructure is one of those places where the cost of doing it casually only shows up later. A weak hardware abstraction layer accumulates defect tickets for years. A flawed manufacturing test stops being a quality control and starts being quality theater. The clients below each had a test or measurement engagement where doing it right mattered more than doing it fast.

Good Automation engaged each client on the measurement integrity work itself: a hardware abstraction layer for a universal Class II ultrasound test set so robust that only one bug ticket was ever filed against it, and that is still in production use today; a redesigned test set that conclusively demonstrated a Class II medical device had been falsely passing manufacturing tests for years, redirecting the engineering investigation from the test system to product failure analysis; and broader test engineering consulting supporting test and measurement infrastructure at a Fortune 500 medical device manufacturer. Three different test contexts, one consistent posture: a test set is the customer's evidence, so the bar has to be that it can be trusted.

Uncovered latent false positives in class II medical device manufac…

For Class II Medical Device Company: Designed a new test set for a medical device.

Ultrasound test set hardware abstraction layer

For Household Name Medical Device Company: Developed a hardware abstraction layer (HAL) for a universal test set used for testing Class II ultrasound machines.

Medical device test infrastructure consulting services

For Fortune 500 Medical Device Manufacturer: Provided test engineering consulting services for the client, a leading medical device manufacturer.

Trusted by

Medtronic GD Energy Products Bell Helicopter Johnson & Johnson GE Healthcare Halliburton Shell Stryker Alcon Abbott Qorvo Qualcomm Keysight Technologies National Instruments MIT Oak Ridge National Lab Ethicon Bridgestone IBM U.S. Department of Energy Georgia Tech Stanford University University of Texas at Austin Verb Surgical Berkeley Lab Pacific Northwest Lab Hewlett Packard Enterprise Gardner Denver Lockheed Martin

Project Highlights

  • 3-project engagement covering complementary scopes under one engineering relationship.
  • Capability mix: Medical Device, Test & Measurement.
  • Engineering scoped to the customer's actual operating context: measurement integrity and device behavior under realistic conditions, without overlaying regulatory boilerplate that did not apply to this engagement.