Software As A Service Medical Device. However there is a new business modelbased on the software-as-a-service SaaS cloud modelthat is being implemented in the. The Client had been looking for a technology partner capable of building an innovative software solution but also familiar with medical device.
However there is a new business modelbased on the software-as-a-service SaaS cloud modelthat is being implemented in the. Software in its own right when specifically intended by the manufacturer to be used for one or more medical purposes is a medical device. Software as a Medical Device SaMD which is a standalone software that serves as a medical product Software in a Medical Device SiaMD which is software that is implemented into a medical product Software as an accessory to a medical device.
This is a broad definition that includes such things as software or mobile apps that are specifically intended to diagnose treat cure prevent or mitigate disease or other conditions.
The Pro4People team implemented it for the UK-based startup. The US Food and Drug Administration FDA defines Software as a Medical Device SaMD as software designed to carry out one or more medical functions. Check out my latest on SaMD and how its being used to change healthcare as we know it. However the regulatory landscape for such innovative.