Main Differences Between SaMD and SiMD

Softwares make our lives easier and they have found a great area in medical device world. The applications and examples of the softwares are increasing day by day in the field of medical devices with various use scenarios. Especially following the doctor communication panels which are developed for hardly diagnosed critical cases, software systems that provides remote patient follow-up and softwares those simulate the operation conditions for surgical planning have already become alive.

It's always much more fun for me to imagine a medical device and move on to the design and development process. However, in order to realize the intended product in compliance with the legislations, the first step is to start by deciding whether software is software as a medical device (SaMD) or software in a medical device (SiMD).

So, what is SaMD?

The International Medical Device Regulators Forum defines the Software as a Medical Device (SaMD) “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The phrase " without being a part of the hardware" mentioned here is actually the most basic indicator that separates the two softwares that are the subject of this article. Software developed for a specific medical purpose, without being part of a hardware, is included in the definition of Software as a Medical Device (SaMD), while software that is part of a hardware and developed for a specific medical purpose is within the scope of Software in a Medical Device (SiMD).

I think the easiest way to distinguish these two definitions is to interpret the software by referring their expansions. So let's give an example of both through the definitions. It must operate completely independently from a medical device to be defined as SaMD. Software that operates and enables us to use devices such as CT, MRI, insulin pumps comply with the definition of SiMD. In other words, we can say that these softwares help us to operate a device. The SaMD device group, on the other hand, can be operated with non-medical computing platforms such as computers, smartphones and tablets.

While SaMD is a software that is not part of a medical device, they often work in conjunction with a medical device. The best example of this would be a software that can monitor and analyze the patient's vital parameters, and give a warning if the parameters are above or below the threshold values or make recommendations for disease diagnosis by analyzing CT or MRI images. I believe this is why, the SaMD devices are confused with SiMDs since they are used together with a device.

If you work in the field of software as a medical device like me, and if you have questions, please do not hesitate to contact us.