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