Difference between revisions of "QIBA for Regulators"
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| − | Medical Device Regulators benefit from QIBA | + | Medical Device Regulators '''benefit''' from QIBA by: |
| − | * Profile documents | + | * 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 |
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| − | '' | + | 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 | ||
| − | [[File:FDA-logo.png]][[File: | + | [[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]] | ||
Latest revision as of 04:19, 19 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
