Can Software Be A Medical Device

Can Software be a Medical Device? 

software as a medical device tracking a heartbeat

We’re currently living in the most technologically-advanced era in human history. Medicine and the devices we use to stay healthy have come a long way, especially in recent decades. Some of the most significant advancements in medicine have come in the form of SaMD, or software as a medical device

What is Software as a Medical Device? 

According to the International Medical Device Regulators Forum, software as a medical device refers to “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” This is somewhat of a broad-sweeping term, but it’s because there are tons of different types of software-based medical devices. 

It’s also important to note that the definition requires the software to be separate from the device using it. SaMD refers to the software itself rather than the device it’s a part of. A good way to determine whether or not the software you’re developing will be considered software as a medical device is how the information or data it produces will be displayed. SaMD doesn’t need other medical devices to display test results. They can use everyday technology like phones, tablets, and TVs that operate independently of medical devices. 

Examples of Software as a Medical Device 

Software as a medical device can refer to anything from the software used as heart rate monitors in smart watches to computer-aided software that helps detect breast cancer. As long as the technology is designed with the intention of being used for medical purposes, it’s considered SaMD. 

This can include software that allows doctors and patients to view the results of their X-rays on a phone or tablet. It can also include software that helps doctors diagnose medical issues and conditions. Here are some specific examples of software being used as a medical device. 

  • Software that can display the results of MRIs, CAT Scans, and other medical tests on tablets and non-medical devices. 
  • Specialized technology that processes images in order to detect things like heart problems and breast cancer.
  • The technology is used to calculate your BMI or how much fat your body has compared to bone and muscle. Software as a medical device refers to the software used in the technology rather than the machine or piece of equipment itself. 

If you think you have a handle on what software as a medical device is, don’t get ahead of yourself. These lists and definitions of software as a medical device imply that any technology used in medicine is SaMD. 

Examples of Software That Isn’t Considered a Medical Device

To help clear things up, here are some examples of what isn’t considered software as a medical device. 

  • Apps or web pages that give people commonly used medical information. 
  • Software or technology is used to service or monitor how other medical devices perform. For example, software that runs diagnostics on MRI machines and makes sure they’re working correctly isn’t considered SaMD. 
  • The tablet or phone you use to view test results uploaded using SaMD isn’t considered software as a medical device. 

As you can see, the line between software as a medical device and just plain software can be confusing. For that reason, you must adhere to the FDA and International Medical Devices Regulation Forum guidelines to make sure your software qualifies as SaMD. 

Different Categories of Software as a Medical Device

The FDA breaks software as a medical device into four separate categories based on risk. While various countries and the bodies that govern their medical industry have different names for these categories, they all mean the same thing. 

SaMD that presents little to no risk of putting a patient’s life in danger is considered Class A, minor, or Class 1. Software that won’t jeopardize a patient’s life but could harm them in some way if it malfunctions is considered Class B, Class 2, or moderate. Software used to keep patients alive or perform advanced surgeries is considered Class C, Class 3, or major in terms of the risk they represent. Class 4 SaMD is reserved for the most high-impact software that’s used to treat or diagnose various diseases and conditions. 

It’s vital that you know what category your software as a medical device will fall into so you know how the FDA will regulate it. 

Who Can Develop Software as a Medical Device? 

Anyone with an eye and gift for software development can create the software as a medical device. Initially, companies that were specific to the medical field developed SaMD. Lately, however, thanks to the growing need for advancements in technology, tech and software companies not related to the medical field have gotten into the game. However, any SaMD you plan to develop must be done in accordance with federal guidelines and must meet FDA requirements

If you are looking for a place to assist you in your software as a medical device development, contact DeviceLab today!