QIBA for Regulators
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