Why Metrology Matters in Medical Device Quality Assurance Testing

Friday, October 6
9:45–11:00 a.m.

This presentation will address the following items as they relate to metrology:

  • The importance of good metrology to patient risk reduction
  • The application of uncertainties to the analysis of the measurements made during medical device quality assurance testing (MDQA)
  • The importance of an unbroken chain of calibration to ensuring the integrity of SI units, and measurements made during MDQA
  • The importance of keeping test instruments properly and timely calibrated and documented as part of their part in the uncertainty chain, and reported as part of a complete medical device calibration verification under ISO 17025
  • Identification of the documentation of the measurements made during medical device calibration verification, and the analysis of those measurements as required for compliance with ISO 17025
  Gerald Zion , Global Training Manager, Fluke Biomedical/RaySafe

Gerald Zion, Global Training Manager, Fluke Biomedical/RaySafe