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5 minutes read

The Importance of Medical Device Software Testing

By Robert Kazmi
medical device software testing
By Robert Kazmi
5 minutes read

The healthcare industry relies on medical device software testing to deliver healthcare devices and treatments that the public can rely on. Medical systems and technologies have evolved significantly and can produce excellent results. 

However, medical devices are no different than any other device that relies on modern technologies and software development. As a result, medical device software is not immune from bugs and other software quality issues. 

If medical device software fails, acts in unexpected ways, or has vulnerabilities, the risk of injury or death is significantly increased. As a result, the development team must prioritize medical device software testing throughout the development process.

Software testing is an essential part of every development process. Still, medical device software has to be tested more vigorously to ensure it doesn’t jeopardize a patient’s health and meets regulatory standards and legal requirements established by regulatory bodies. 

This post will examine the importance of medical device software testing in greater detail so your organization can understand the testing activities necessary in the healthcare sector. 

Testing Software for Medical Devices

Testing medical device software is not as simple as software testing a mobile application. Medical device software does not exist in a vacuum. This software and its performance are directly related to the medical device it is built for. 

In many cases, a medical device might be developed alongside the software, complicating the testing process. 

Not only does the medical software have to be tested to ensure there are no security threats or performance issues, but the software must also be tested with the function of the medical device. 

Medical device manufacturers must ensure that their medical devices deliver accurate information, perform optimally, and are safe to use. In addition, these medical devices must meet functional safety standards before they can even be introduced to healthcare providers.

As a result, to test medical device software effectively, medical device manufacturers must employ a robust testing strategy to find any vulnerabilities, bugs, or technical issues in the medical devices or the software running them. 

Due to the complexities of medical device testing, many manufacturers will employ medical device testing services to ensure that they meet regulatory requirements and achieve compliance. 

Quality Assurance and Software Testing for Medical Devices 

Quality assurance and medical device testing involve several tests and procedures to ensure such devices and the underlying software are safe and function as expected. 

The medical software testing process aims to remove defects in software architecture, code, performance, etc. Ensuring regulatory compliance and the production of world-class devices is the primary goal.

Medical device testing is a multifaceted process that involves the following: 

  • Functional testing
  • Device verification testing 
  • Device validation testing 
  • Device compatibility testing
  • Automated testing 

Functional Testing 

In this stage, the functionality of the software running on the medical device is tested and verified. These tests aim to ensure the software is performing as expected per the design specifications. 

Performance testing is also conducted to ensure that the software runs optimally. The test data gathered and documented in the test results report will be used to make modifications, if necessary, to optimize performance. 

Functional testing is a critical part of feature development. These tests verify that a feature or function works as expected. 

Unit testing features is an essential part of development, and automation tools don’t always achieve complete code coverage, so manual testing of features should be expected during this process. 

Device Verification Testing 

Device verification testing is the process of confirming that the medical device satisfies the requirements of the design inputs. Typically, there are management systems that can help testing teams compare the design input versus the design output. 

There are no automated tests for this process. Instead, verification requires manual work to ensure that the device being developed is the device that was designed. This may sound like a simple process, but mistakes in this stage can lead to serious problems.

Device Validation Testing 

The objective of device validation testing is to confirm that the medical device meets the needs of end users. End users for medical devices are typically doctors, nurses, technicians, or patients. 

If a device does not meet user needs or fails to perform as expected in real-world conditions, it must be redesigned before it can go into mass production. Therefore, testing medical devices under the strains of real operating environments is important to ensure they work. 

Safety-critical software and devices that fail to perform when counted on cannot be released to the public. 

Device Compatibility Testing 

Medical devices often need to operate with other devices, databases, networks, etc. Device compatibility testing ensures that a device is compatible with databases, mobile apps, networks, configurations, and more

A device that doesn’t work well with other tools and devices is of little value in healthcare, where there are a lot of tools in use to treat patients and organize data. In addition, compatibility is often a prerequisite to proving compliance. 

Automated Testing 

Automated testing is used to streamline some of the manual tasks associated with testing. Of course, you can’t rely solely on test automation to ensure the quality of your software and device, but it can help expedite testing and ensure complete code coverage. 

Test automation and other QA tools can help testers catch bugs and vulnerabilities they might have missed. Of course, any robust test plan will include automation, but it won’t rely on this type of testing for everything. 

Final Thoughts 

Software testing is a critical part of development. Testing is even more critical when software is running on devices that serve medical needs. 

If your organization wants to learn more about the importance of medical device software testing or available testing services, reach out to an experienced team of IT professionals and QA testers like Koombea.

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