QIBA Conformance Certificate Services and Self-Attestation Procedures

QIBA Self Attestation Conformance Certification Conformance Marks

QIBA┬« is now supporting both new conformance testing services and self-attestation procedures to help clinical sites and imaging CROs (Core Labs) demonstrate they can achieve high-quality quantitative imaging results. A clinical site, or CRO, that achieves QIBA Profile specifications for a given Profile can receive a QIBA Conformance Mark (Certification or Self-Attestation) that can be used to distinguish itself as performing quantitative imaging studies with high levels of precision. Scanner and analysis software vendors can also obtain the QIBA Conformance Marks to certify their specific medical device(s) or software has been tested and has demonstrated conformance with a given QIBA Profile. 

Profiles that have reached the Consensus Stage and have developed either a Self-Attestation Procedure or a Conformance Certification Service (including an image quality assessment phantom and online phantom analysis services) are eligible. 

 

QIBA consensus profile flow chart

 

Certified Conformance
Registered Conformance

 

Benefits of obtaining a QIBA Conformance Certification or Self-Attestation Mark for a clinical site or imaging CRO:

  • Confirm that your clinical site or CRO is delivering high quality imaging measurements to patients or sponsors.
  • Quantitatively identify, optimize and monitor any potential image quality performance issues.
  • Obtain high-quality measurements based on fundamental image quality characteristics and imaging protocols which can be useful when conducting clinical trials and algorithmic imaging research.
  • Promote your high-performance, quantitative imaging capability by posting the QIBA Conformance Mark to your website and imaging site materials.
  • Participation will help improve future quantitative imaging guidelines.

 

Benefits of obtaining a QIBA Conformance Certification or Self-Attestation Mark for a scanner or software vendor:

  • Demonstrate to your current and potential customers that your medical device or software meets the thorough specifications outlined in a QIBA Profile.
  • Annually verify the performance of your medical device helping ensure that the high performance remains consistent under a variety of acquisition and measurement conditions.
  • Provide quantitative and independently confirmed device data to your customers on the best methods and protocols to use with your medical device.
  • Promote your high-performance, quantitative imaging capability by posting the QIBA Conformance Certification Mark to your medical device or software web pages and promotional materials.
  • Participation will help improve future quantitative imaging guidelines.

 

List of Registered and Certified Organizations

Contact us

If you have any questions, please contact our staff at qiba@rsna.org.