Is my software SaMD or SiMD?


At SAASCO trainings we always strive to use the Hungarian terminology and abbreviations of the given field and avoid the "hunglish" language that is so fashionable nowadays. However, this is becoming increasingly difficult, especially in the field of software.

What do the abbreviations SaMD and SiMD stand for?

SaMD is defined by the IMDRF (International, Medical Devices Regulatory Forum). According to the definition, SaMD, Software as a Medical Device, is "one or more pieces of software intended for medical purposes that accomplish those purposes without being part of a hardware medical device".

For a product to be classified as a SaMD, the software must be independent of any hardware, i.e. it must be able to run on a general (non-medical) computing platform. This does not, of course, exclude that SaMD cannot be used in combination with other products, including medical devices.

Let's look at some examples of SaMDs:

  • Software that allows a mobile device to view images from an MRI, ultrasound or X-ray scan used for diagnostic purposes.
  • Software that processes images to detect breast cancer.
  • Software that collects patient data in real time, monitored by a healthcare professional and used to develop treatment plans.

Now the picture is clearer, but what do we call SiMD?

A hardvereszközök meghajtására, vezérlésére vagy felügyeletére használt szoftverek nem férnek bele az SaMD definíciójába. Ehelyett az ilyen típusú szoftvereket SiMD-nek nevezzük, azaz “Software in a Medical Device”, magyarul “szoftver egy orvostechnikai eszközben”.

Software used to drive, control or monitor hardware devices does not fit the definition of SaMD. Instead, this type of software is referred to as SiMD, i.e. "Software in a Medical Device".

Simply put, any software that helps you operate a hardware medical device - say by driving its mechanics or creating a graphical interface - is a SiMD. Some examples:

  • Software that controls the inflation or deflation of the blood pressure cuff.
  • Software that controls the delivery of insulin to the insulin pump.
  • Software used to control the closed loop of the pacemaker.

This type of software is also called "firmware" or "embedded software".