ISO 13485 Certification

Radiomics.bio’s quality management system (QMS) for medical devices and services is ISO 13485 certified as of January 2022, following the audit of the notified body IMQ.

This certificate covers the design and development of Software as a Medical Device used for the diagnosis, prognosis or prediction of disease progression which are typically assessed through routine clinical imaging. As Radiomics.bio is doing more than just designing and developing medical devices, it has decided that Radiomics’ quality management system should also cover our other activities.

The document to certify that our quality management system is evaluated and complies with the ISO requirements can be found here.