Glossary of Terms

Software as a Medical Device (SaMD) and Examples

SaMD & Digital Health
Compliance & Regulatory: MedTech

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.