What Role Does Quality Assurance Play in Medical Device Testing?

The healthcare sector has witnessed a breakthrough in the diagnosis and treatment of diseases with the advent of advanced medical technologies in the last few years. The breakthrough has enhanced the accuracy and efficacy of medical systems and streamlined the management of processes in healthcare. In this context, it is important to know the role of quality assurance and how it brought about a qualitative change in the delivery of treatment, especially during the pandemic through tele-medicine.

Medical devices are essential in the healthcare industry as they help in the prevention, diagnosis, and treatment of illnesses. Medical device testing has become crucial due to the growing complexities of software embedded in medical devices. The quality of such embedded software can be affected by a plethora of factors like hidden glitches, regulatory delays, and threat actors, among others. To meet the growing demands and to ensure the reliability of these medical devices, quality assurance has become the need of the hour. In this article, we’ll talk about medical device software testing and the importance of delivering quality assurance (QA) as a part of this testing service.

Medical Device Testing: A Brief Understanding

Medical device testing involves various strategies to ensure the device is safe and delivers accurate readings and optimal performance while in use. This is one of the most critical steps towards transforming an innovative product design into a successful marketable product. These devices need to comply with certain regulatory standards before they are released for actual use in the healthcare segment. Therefore, it’s important to have a robust testing strategy in place to identify any hidden glitches or vulnerabilities in such devices or the software running them. This is where a medical device testing company can assist you. They’ll prepare and implement a comprehensive test strategy to ensure the software complies with all regulatory standards and meets all quality-related outcomes. This is where Quality Assurance (QA) plays an integral role.

Let’s now understand the role played by QA in testing medical devices.

Quality Assurance – Procedures and Benefits

Quality Assurance (QA) involves a wide range of systematic procedures that effectively monitor the design process of medical devices and ensure all quality-related aspects are fulfilled. This testing process involves the removal of any possible defects in the device and improvement in the processes to make the device safe while in use. It’s the role of QA experts to implement a robust test strategy to ensure the delivery of high-quality products. Also, QA is not a single process; rather, it includes a combination of processes to detect possible manufacturing flaws in a device. As shown below, there are several methods used to validate the quality of a medical testing device:

Functionality Testing: Here, the functionality of the software application running on the medical device is verified. The main objective is to see if the medical device software is functioning as per the designed specifications.

Device Verification Testing: This procedure follows a standard methodology to make a comparative study between the current product requirements and the requirements that have already been approved.

Device Validation: The primary objective of medical device software validation is to check if it meets the specific requirements of the end users (doctors, technicians, and patients). In this process, the device is tested under real operating environments to ensure its efficiency.

Device Compatibility: If a medical device is found to be compatible across databases, browsers, operating systems, networks, and hardware configurations, it is considered safe to use.

Automated Testing: This kind of testing is done to remove the hassles of manual work. It streamlines the testing process, thus making it faster, more complete, and more accurate.

Now that you’ve understood the methods involved, let’s take a close look at the various benefits of Quality Assurance (QA).

l Ensures the medical device meets various compliance regulations and internal quality standards

l Verification and validation of medical devices in various fields like dentistry, cardiology, surgical, and orthopedics, among others.

l Enhances the clinical effectiveness and efficiency of medical devices

l Risk-based testing ensures device compatibility and helps in continuously modifying the problem areas

Conclusion

Medical devices are critical since they directly impact the health and well-being of patients. Therefore, medical device testing is an absolute necessity to ensure optimal performance of these devices while in use. End-to-end testing helps in overcoming some of the biggest challenges, like device compatibility, security breaches, and cloud adoption. Any kind of performance issue could pose a great risk to the patient’s health, including leading to fatality. So, the healthcare sector needs to avail medical equipment testing services to ensure the reliability, safety, and effectiveness of the devices in use.

James Daniel is a software Tech enthusiastic & works at Cigniti Technologies. I'm having a great understanding of today's software testing quality that yields strong results and always happy to create valuable content & share thoughts.