Imagilys on the Road to Certification!

ISO 13485, IEC 62304:2006, ISO14971, DICOM implementation are now in progress.

fMRI software have undergone large developments in the research community for the last 10 years. Although already used for clinical purposes in several centers, no reliable fMRI software has been certifed by regulatory authorities (FDA, EC mark,...). On the one hand there are the powerfull but uncertified software like SPM, and on the other some manufacturers offer certified but very basic fMRI analysis tools.

Imagilys which aim is providing user-friendly but powerfull fMRI tools has chosen to develop quality insurance procedures for its products. Emergo, a consulting firm specialized in medical devices quality insurance, will lead these structural changes. ISO 13485, IEC 62304:2006, ISO14971, DICOM implementation is now in progress.