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