Difference between revisions of "QIBA for Regulators"

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Medical Device Regulators benefit from QIBA through:  
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Medical Device Regulators '''benefit''' from QIBA through:  
 
* Profile documents that include device and user tasks necessary to achieve a specific quantitative imaging performance claims
 
* 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  
 
* 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  
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Medical Device Regulators can use QIBA:  
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Medical Device Regulators may also use QIBA:  
 
* To understand consensus approaches for evaluating specific quantitative imaging device claims
 
* 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 communicate current thinking from the quantitative imaging community to medical device developers on test procedures and statistical analysis methods
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* As a source for phantom designs or image data to  support quantitative imaging device assessment
 
* 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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''(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 19:31, 15 October 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 datasets that can be used by device developers to standardize assessment of image acquisition systems and quantitative imaging devices


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 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

CFDA-logo.png Pmda-logo.png MFDS-logo.jpeg FDA-logo.png

TGA-logo.png ANVISA-logo.jpeg EC-logo.png Health-Canada-logo.jpeg