Difference between revisions of "QIBA for Regulators"
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| − | Medical Device Regulators benefit from QIBA through: | + | 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 | ||
| Line 10: | Line 10: | ||
| − | Medical Device Regulators | + | 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 | ||
| Line 16: | Line 16: | ||
* 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 | + | ''(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
