We're a software based medical diagnosis company based in India. We're looking to enter US market with our product. We take patients biometrics and our algorithms suggest the diagnosis based on it. Recommending Lab tests and doctor consultation are other optional things we do.
Could anyone help me understand whether we fall into the category of software as a medical device (SaMD). And if that is the case, what category out of the class 1,2,3 would we likely fall under?
0 nhận xét:
Đăng nhận xét