By Walt Maclay
Download CalibrationDisposableMedicalDevices.pdf (reprinted with permission from Embedded Computing Design)
FDA regulations for medical devices require manufacturers to develop and monitor production practices to ensure that the end device conforms to its specifications. A calibration program is a major part of this quality system to verify the accuracy and precision of measurements. Walt describes the techniques, tools, and equipment used to calibrate a disposable medical device.
Medical devices that rely on one or more embedded sensors not only need testing, but also sensor calibration. Digital circuits can be subject to pass/fail testing. However, sensors require precise testing or calibration to be accurate. Calibration ensures that different individual devices give the same result. Sensors needing calibration include temperature, pressure, acceleration, strain, and displacement.