In recent times, as technology advances, software has become an important part of medical devices. It is important to highlight that the software can be considered as a medical device in itself or can be considered as an integral part of a medical device (software in a medical device).
It is important to clarify these differences, since they help define the regulatory strategy to be followed when registering your medical device.
The Software as a medical device, is the software intended to be used for one or more medical purposes without being part of a hardware medical device, this software is independent of the fact of needing hardware to run.
“non-part of” means that the software is not necessary for a hardware medical device to achieve its intended medical purpose.
The software as a medical device can be used on a wide range of technology platforms, including medical device platforms as long as this software is not necessary to achieve the intended use of the medical device.
If the intended purpose is to control a hardware medical device, then the software is not considered as a medical device itself, but as an integrated hardware medical device.
Regarding the documentation required for the presentation of a medical device as software or a medical device that includes software, it is generally the same documentation that would be generated during the Software Design and Development process, therefore, if the software was developed in In such an environment, any documentation generated should be sufficient for the presentation of your device.
However, there are reference guides from the FDA and the International Medical Device Regulators Forum (IMDRF) that are not intended to be binding on device approval, but serve as guidance to ensure that the entire process required for Design has been covered. and Device development.
If your intention is to register a medical device with software or software as a medical device, contact us and we will provide you with all the necessary advice to register your device.