Software verification of medical instruments and equipment

The software is classified as 6870 in the medical device classification catalogue, and the specific category depends on which direction your product is. If it is diagnostic data processing software, it is divided into two categories. If it is diagnostic image processing software, it is divided into two categories and three categories, and there are other directions. According to the different specific functions, the software is either Class II or Class III, and most of them belong to Class III, which generally needs clinical verification. Clinical trials mainly depend on whether your software is therapeutic or not. If it is, it can be exempted from the trial, but it needs clinical evaluation and comparison with the data of similar products.