A matter of life or death | Fluke Biomedical
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A matter of life or death

For medical devices, ISO/IEC 17025 compliance matters a great deal to the device manufacturers, the hospitals and the patients. For manufacturers metrology involves:

  • Research and development—validation of design concept, validation testing
  • New product introduction—setting product specifications
  • Operations—calibration and verification during the manufacturing process
  • Quality—supporting lean manufacturing, final inspection, and conformance
  • Service—calibration and verification
  • Sales and marketing—making/delivering claims to specifications

At the hospital level, where the use of the devices is critical to patient care, metrology involves:

  • Meeting strict regulatory requirements for patient safety
  • Choosing adequate medical instrumentation • Verification and adjustment of medical devices
  • Service and repair

If these processes are not handled in-house at the hospital, then choosing capable and competent vendors to support and maintain deployed instrumentation is crucial. For patients, even though they may not be aware, metrology and a trusted laboratory partner really matter when instruments could save a life.

 

Interested in learning more about metrology and accreditation? Visit here

Looking to service your device? Click here