Hi all,
I have a class IIb medical device (a CBCT scanner for extremities) for only diagnostic purpose; is there a required software classification.
The software manages images acquisition, 3D Reconstruction and visualization on the viewer; no further decision is taken automatically.
I suppose I can assume class B, due to the risk mitigation measures (other than the software).
But my question would be:
is there any guideline defining the difference between serious injury and not serious injury? I only found some docs produced by specific Department of Health, but not an international standard definition.
Thanks
I have a class IIb medical device (a CBCT scanner for extremities) for only diagnostic purpose; is there a required software classification.
The software manages images acquisition, 3D Reconstruction and visualization on the viewer; no further decision is taken automatically.
I suppose I can assume class B, due to the risk mitigation measures (other than the software).
But my question would be:
is there any guideline defining the difference between serious injury and not serious injury? I only found some docs produced by specific Department of Health, but not an international standard definition.
Thanks