Difference between revisions of "QIBA for Regulators"

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Revision as of 19:26, 20 August 2019

QIBA Mission: Improve the value and practicality of quantitative imaging biomarkers by reducing variability across devices, sites, patients, and time.

QIBA develops Profile documents that standardize methods for creating a specific biomarker with predictable performance (accuracy and reproducibility).

Medical Device Regulators benefit from QIBA through:

  • Profile documents that include device and user tasks necessary to achieve a specific quantitative imaging performance claims
  • Conformance testing that can be used by device developers with consensus test and analysis methods for standardized assessment of image acquisition systems and quantitative imaging devices
  • Development of dataset that can be used by device developers to standardize assessment of image acquisition systems and quantitative imaging devices

Medical Device Regulators can use QIBA:

  • To understand consensus approaches for evaluating specific quantitative imaging device claims
  • To communicate current thinking from the quantitative imaging community to medical device developers on test procedures and statistical analysis methods
  • To potentially serve as a resource for device developers in conducting their own conformance testing in to support a regulatory submission
  • As a source for phantom designs or image data to support quantitative imaging device assessment

(Like Keven's for Vendors, A bit of graphics/color would be nice - Maybe something from FDA which look regulatory in some way. One thought woudl be to use regulatory logos (FDA logo isn't copyrighted) but best to include include other regulatory agencies as well to make it global