QIBA for Regulators

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Revision as of 19:35, 20 August 2019 by Npetrick (talk | contribs)
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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 datasets 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 might be to use regulatory logos (FDA logo isn't copyrighted) something like this

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