Disease aided diagnosis software system, apply for several types of medical devices, need to do clinical verification

Software in the medical device classification directory classified as 6870, the specific class depends on the specific direction of your product, if it is diagnostic data processing software are class II, diagnostic image processing software, then there are sub-class II and III, and other directions, depending on the specific function of it, the software is either class II or III, and most of them belong to the third class, the third class are generally required to do clinical verification. Clinical trials, if you mainly look at your software is not a therapeutic class, is that if you can be exempted from the test, but to have a clinical evaluation, to be compared with the data of similar products.