Software as a Medical Device (SaMD) is any standalone software that is intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Software that provides parameters that become the input for a different hardware medical device or other Software as a Medical Device. For example, treatment planning software that supplies information used in a linear accelerator is Software as a Medical Device.
Some examples of SaMD can include:
- Magnetic Resonance Imaging (MRI) software
- Computer-Aided Detection software (CAD)
- X-Ray Imaging software
- Software that collects patient data (blood pressure, heart rate, temperature...)
- Applications that analyze and calculate the dosage of medicine for a patient.
The increasing popularity of Software as a Medical Device can be attributed to the fact that it can be used across a broad range of technology platforms like medical device platforms and virtual networks. SaMD is showing us that there is a growing space for medical device companies with new and innovative technologies that will continue to progress the future of healthcare for the better.