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What is Software as Medical device and why it matters

Chief Marketing Officer
Oct 28, 2021 • 3 min



Emerging technologies and digitalization have a huge impact in the healthcare industry as they can streamline processes, increase transparency, ease communication between all parties, improve response times and provide quick diagnoses. 


Software solutions are the core of multiple MedTech apps and HealthTech solutions, and they are integrated across a variety of products and platforms - be it medical or non-medical. 


What types of software solutions are related to medical devices? 


There are 3 types of software solutions related to medical devices:

  • software as a medical devices
  • Software in a medical device
  • software used in the manufacture or maintenance of a medical device

What is Software as a medical device and how can you use it? 

Software as a Medical Device is described by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."


Software as a Medical device examples:

  • Software solutions used for Screening, diagnosis, treating, alleviating, or preventing different conditions.
  • Mobile applications to monitor, alert and facilitate patients’ pain management, arrhythmia management, and blood glucose monitoring. 
  • Apps used for Chronic condition and disease management
  • Any solution, be it website or mobile, used for digital therapeutics


To put it bluntly, software as a Medical Device can be anything from a mobile app to any software that helps patients, by functioning independently from another medical device hardware; It can use the data from a device, but it is not connected to it. 


Think about all the software solutions helping the medical staff to analyze X-rays and MRIs - while there are plenty of devices to take a scan, there are also plenty of software solutions helping you diagnose conditions based on the results. 


What is Software in a medical device, and how common is it?


  • Software in a medical device

to keep the example we've mentioned above, there are multiple software solutions to help radiologists diagnose different conditions when they check a scan, but the software that transforms the MRI magnets into an Xray or something you can look at or if we are thinking about an interface to control the device, then we are looking at Software in a Medical Device. 


Build Your Software as a Medical Device with us


We have what it takes to build health apps for prevention, diagnosis, intervention, treatment, recovery, and patient management & communication, and we look forward to working on the next meaningful medical software, especially in these times.


We really know how to work with health professionals

Got a health startup, or are you looking to digitalize any health services or any part of the medical act? Get in touch with us and let’s talk





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