Dear all,
Currently I am involved with medical device software which can be considered a PACS plugin. What I mean with this is that the PACS is the non-medical device part, while the plugin modifies an image in such a manner that it is a medical device. The basic principle is that you have an image as input for the plugin and a modified image is output, thats it. There is no user interface. It is just, image in, image out.
Question: would you just rationalise that no usability study is needed?
Currently I am involved with medical device software which can be considered a PACS plugin. What I mean with this is that the PACS is the non-medical device part, while the plugin modifies an image in such a manner that it is a medical device. The basic principle is that you have an image as input for the plugin and a modified image is output, thats it. There is no user interface. It is just, image in, image out.
Question: would you just rationalise that no usability study is needed?