Hi, I have used 3D slicer to evaluate the extension of a thermal treatment damage in soft tissue on CT and CBCT dicom datasets (the images were visualised and the data evaluated with markups tool). These data will be part of the treatment device submission documentation under EU-MDR. I am looking for software qualification or validation documentation. Is there any quality assurance support available? any support/indication would be useful. Thanks, Laura
Slicer is available for free and many people use it for published research but it’s not a product and doesn’t provide regulatory documentation.