Role of QA in Medical Device Software Testing

In recent years, the healthcare sector witnessed numerous innovations with the evolution of digitization processes. Especially due to COVID-19, the medical industry went through a sudden change. Whether it’s telemedicine, virtual care facilities or virtual reality in healthcare, the level of healthcare technologies has grown many folds. The medical device embedding software is also delivering better healthcare services. They have become vital for patient care as they provide critical data and observations regarding their health.


Now, due to the growing demand for digital health facilities, the complexity of medical device software is also growing. Certain factors like regulatory delays and international standards also affect the quality of medical device software. This is why you need to partner with a professional medical device software testing company that can handle the quality assurance process of healthcare applications. 

What is Medical Device Software Testing?

Medical devices have to satisfy a set of standardizations and compliances since they are heavily regulated by various regulatory bodies. They should also deliver accurate readings, results, effective performance, and should meet all security standards. That’s why it is important to ensure that medical software and devices are compatible and compliant with various functionalities and regulations. Medical device software testing ensures that the device fulfills quality-related standards successfully.

Role of QA in Testing of Medical Devices

Glitches in medical software may cause false diagnosis results, which is why QA is an essential component to ensure the proper functioning and performance of healthcare devices.

  • Helps in enhancing medical devices’ clinical effectiveness
  • Ensures medical device software, mobile apps, healthcare CRM, and database management system work seamlessly
  • QA testing ensures the effectiveness and quality of medical devices to provide excellent patient care
  • Integration testing ensures seamless connectivity with other devices
  • Mitigate the risk of device failure with end-to-end device testing
  • Ensures compatibility with regulatory compliances such as FDA, HIPAA, and PCI DSS


QA Methods for Medical Software Testing

Implementing an effective testing strategy will help you achieve successful healthcare software testing based on test case requirements. By properly evaluating the requirements, you can smoothen the implementation of test cases on medical device software. There are various QA methods that testing companies use to test healthcare software.

  • Automation Testing

Firstly, automation testing eases the testing process and replaces manual tasks to ensure speed and quality. Secondly, it makes the QA process more accurate, complete, and faster. It includes:

  • Recording results
  • Stimulating the device
  • Control entire QA process
  • Monitor device response
  • Declare results


When working with automated testing, the QA team needs to implement strategies based on test options available during each medical software development stage. It allows the testing engineers to address any challenge with ease in the test automation environment.

  • Functionality Testing

Firstly, functionality testing focuses on device performance under various scenarios. Secondly, it involves the verification and validation process of the device. Each function gets tested with a combination of parameters to get exact data on software functionality.

  • Validation Testing

Firstly, the primary purpose of validation testing is to ensure that software meets specific user needs. Secondly, the QA teams run tests under simulated or actual environment conditions to analyze how the software functions. 

  • White-box Testing

White-box automation testing is necessary to ensure that the testing process is compatible with design and coding phases. It allows the QA team to have an inside look at medical device software. The test cases monitor: overflow conditions, interrupt handling, timing interactions, and error counts.

  • Verification Testing

This type of testing verifies whether the product fulfills the specified requirements or not. The process consists of well-defined product requirements that the QA team measures to verify. It follows certain protocols and utilizes methodology to compare current product requirements with approved ones. In case the process fails, then further investigation is done to find which requirements don’t meet the criteria. It helps in sorting the requirements that you can update.

  • Error Handling Testing

It is important to test software compatibility across multiple devices, operating systems, and browsers. You have to also check how well it responds under certain error conditions like internal failures and power fluctuations. The software should be able to deliver a proper error message to let users know about the issue.


Quality assurance testing plays a crucial role in improving the accuracy of medical device software testing. Instead of establishing an in-house QA team, the best option is to outsource healthcare software testing services to a professional QA company. QASource provides cutting-edge and highly compatible software testing services for medical devices. To know more about healthcare software QA, contact QASource now.