QIBA for Regulators: Difference between revisions

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Medical Device Regulators '''benefit''' from QIBA through:  
Medical Device Regulators '''benefit''' from QIBA by:  
* Profile documents that include device and user tasks necessary to achieve a specific quantitative imaging performance claims
* using Profile documents to verify 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
* using QIBA '''assessment procedures''' to standardized assessment of image acquisition systems and quantitative imaging functions
* Development of datasets that can be used by device developers to standardize assessment of image acquisition systems and quantitative imaging devices
* using QIBA '''datasets and referenced phantom designs''' to standardize assessment of image acquisition systems and quantitative imaging devices




Medical Device Regulators may also '''use QIBA''':  
Medical Device Regulators may also '''use QIBA''':  
* To understand consensus approaches for evaluating specific quantitative imaging device claims
* To communicate current thinking from the quantitative imaging community on test procedures and statistical analysis methods to stakeholders such as medical device developers  
* 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 Kevin'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''


[[File:CFDA-logo.png|120px]]  [[File:Pmda-logo.png|230px]]  [[File:MFDS-logo.jpeg|160px]] [[File:FDA-logo.png|120px]]
[[File:CFDA-logo.png|120px]]  [[File:Pmda-logo.png|230px]]  [[File:MFDS-logo.jpeg|160px]] [[File:FDA-logo.png|120px]]


[[File:TGA-logo.png|130px]] [[File:ANVISA-logo.jpeg|80px]] [[File:EC-logo.png|140px]] [[File:Health-Canada-logo.jpeg|170px]]
[[File:TGA-logo.png|130px]] [[File:ANVISA-logo.jpeg|80px]] [[File:EC-logo.png|140px]] [[File:Health-Canada-logo.jpeg|170px]]

Revision as of 21:47, 5 November 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 by:

  • using Profile documents to verify specific quantitative imaging performance claims
  • using QIBA assessment procedures to standardized assessment of image acquisition systems and quantitative imaging functions
  • using QIBA datasets and referenced phantom designs to standardize assessment of image acquisition systems and quantitative imaging devices


Medical Device Regulators may also use QIBA:

  • To communicate current thinking from the quantitative imaging community on test procedures and statistical analysis methods to stakeholders such as medical device developers


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