Software as Medical Device is any class of software embedded or otherwise that is used as per the claims of the software manufacturer for treating a medical condition.

The official definition of SaMD is captured here: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf

The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

NOTES:

• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.

• SaMD is capable of running on general purpose (non-medical purpose) computing platforms.

• “without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose.

• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.

• SaMD may be used in combination (e.g., as a module) with other products including medical devices.

• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software.

• Mobile apps that meet the definition above are considered SaMD.