Difference between revisions of "QIBA for Regulators"
Jump to navigation
Jump to search
| Line 12: | Line 12: | ||
Medical Device Regulators may also '''use QIBA''': | 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 | * To communicate current thinking from the quantitative imaging community on test procedures and statistical analysis methods to stakeholders such as medical device developers | ||
| − | |||
| − | |||
[[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 21:48, 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
