Software Freedom Day
Check How Software Developments are changing and developing the MedTech Industry!
Medical Devices are evolving with the development in technology and advancing healthcare requirements. MedTech companies collect patients’ performance information, which creates a crucial data trend in the MedTech Industry. It is essential to understand what exactly SaMD (Software as a Medical Device) is in such advancing times.
IMDRF defines “Software as a Medical Device” (SaMD) as a software used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Any algorithm, code, or software program used for medical purposes and is not a part of a hardware medical device will be classified as SaMD. A thin line of difference is stated in MDR classification where - Software for general purposes, even when used in a healthcare setting, or software intended for lifestyle and well-being purposes is not a medical device.