quality assurance medical device testing

Published: 14 Jan 2020

Why Quality Assurance is Critical for Medical Device Testing?

Last Updated: 05 Jan 2024

The healthcare industry in recent years has seen numerous innovations with digitization. This has helped in connecting people more effectively with the latest medical devices embedding software that delivers better healthcare services. Medical devices are vital for patient care as they directly impact human lives by providing critical data and observations derived by using them.

The medical device software continues to become more complex due to various advances in healthcare. There are certainly important and compliance factors such as regulatory delays and the adoption of international standards that affect the medical device’s software quality.

1. What is Medical Device Testing?
2. What is the Role of QA in Medical Devices Testing?
3. What are the Methods Followed by QA for Medical Device Software Testing?
4. What are the challenges Faced with Medical Device Testing?
5. Conclusion

What is Medical Device Testing?


Medical devices are regulated mainly by multiple regulatory bodies and have to satisfy a set of compliances and standardizations. Moreover, they should deliver effective performance, accurate readings and should be safe while at use.

Therefore, it is essential for medical devices to have a proper device testing strategy in place. The approach consists of maintaining compliance processes and planned software testing approach to deliver device effectiveness.

Medical Device testing ensures the product’s software and devices are fully compatible and compliant with various regulations and functionality. This testing ensures that these devices fulfill all quality-related aspects successfully for which QA plays an important role.

Hence, medical device manufacturers should adopt quality assurance (QA) for thorough verification and validation of devices. It ensures to deliver the proper quality and reliability of these devices.

What is the Role of QA in Medical Devices Testing?

  1. Ensures compliance testing with various regulations such as HIPAA, PCI DSS, and FDA, etc.
  2. Ensures healthcare CRMs, patient mobile apps, medical devices software, and Patient Database management systems work seamlessly under various scenarios
  3. Integration testing of devices ensures proper connectivity with other devices
  4. Helps to improve the clinical effectiveness of medical devices
  5. Adequate testing ensures the quality and effectiveness of various medical devices to provide optimal patient care
  6. End-to-end devices testing mitigates any risk of device failure

Further, glitches in medical device software may lead to false diagnosis and hence QA is essential to ensure proper performance and functioning of medical devices.

What are the Methods Followed by QA for Medical Device Software Testing?


Having an effective testing strategy helps to achieve successful medical device testing which is based on several sets of test requirements. These requirements are based on various component specifications, manufacturing processes, and other critical functional specifications of the devices and software.

Further, proper evaluation of the sets of requirements smoothens the test implementations as tests can be carried out effectively on the software of medical devices.

Different parameters have to be tested to ensure device functionality. There are various methods for medical device software testing.

1. Functionality Testing:


It focuses on test efforts to evaluate how the device is supposed to perform under various scenarios. It involves the actual process of verification and validation of devices. Each of the functions is exhaustively tested with a combination of parameter values to know the device’s functionality.

2. Device Verification Testing:

Device Verification Testing

This process confirms whether the examination of any objective evidence with specified requirements of the device has been fulfilled or not. The process starts with clear and well-defined product requirements which must be measurable in order to verify them.

The process follows certain protocols and uses a standard methodology that compares current product requirements with already approved requirements.In case, if the device verification process fails, then it is essential to undergo further investigation to find the requirement that couldn’t meet the expectation. Then, a further investigation will help to sort out whether the requirement can be updated or not.

A perfect medical device strategy can save money for the enterprises and ensures the device meets the required expectations with the least device risks and reduced testing time.

3. Device Validation (Software/Hardware) Testing:


After the entire system is in place, then medical devices should be validated for both software & hardware. The primary purpose of this validation process is to test if the device meets specific user needs or not. It can be tested under simulated or under actual environment conditions to know how the software and hardware function.

Unit testing is the initial approach that is practiced by considering a set of stages or blocks in the process. Later, the entire system is validated as a whole. However, based on the system complexity, it can be a daunting practice for the automated test system. In such cases, the efficient way is to adopt a divide and validation approach.

4. Device Compatibility & Error Handling Testing:


Medical device’s compatibility across various devices has to be tested to prove its success. It is essential to test how the device responds under various error conditions especially under power fluctuations, internal failures or for any peripheral device failure. The devices should deliver proper error messages to notify users.

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5. Automated Testing:


This form of testing is taken up to ease the testing process and overcome manual tasks to ensure quality at speed. The automated testing makes the qa process faster, more accurate and complete. Primarily, the process includes stimulating the target device, monitor the device response, record the results, control the entire process using automation and declare results.

While opting for the test automation system, the testing teams need to adopt the strategies based on the test options achieved in each medical device development stage. In case, the testing strategy is for complex devices that use extreme voltage and current, then it is essential to break down the test specifications into hardware and software requirements based on the interfaces as hardware and software. This will prevent the testing teams from facing any sort of challenges in the test automation environment.

6. White-Box Testing:

White-Box Testing

Automation of white-box testing is essential as it ensures the testing process to be closer to the design and coding phases of the project. It is necessary to introduce an automated test system that enables an inside look at medical device software. Tests are devised to monitor various parts to check any overflow conditions, timing interactions, interrupt handling, error counts, etc.

What are the challenges Faced with Medical Device Testing?

Challenge with Device Compatibility:

Testing the healthcare apps for web and mobile compatibility is one of the important challenges faced in medical device testing. In the present world, most of the people rely on mobile platforms for almost every need. Hence, it is essential to optimize the healthcare app for several mobile devices and different operating systems. It is also essential that the apps should be easily accessible, provide the security for every information provided by the user, and at the same time should help to receive every required update.

Challenge to overcome security breaches:

Security is one of the important requirements for every medical app. With the rampant cyber-attacks on various apps, any security breach will cost the company some fortune. Hence, to avoid such scenarios, it is important for businesses to leverage security testing by the next-gen testing services provider.

They have the right skills set and security testing tools for enabling effective security testing and penetration testing of these medical devices apps. Therefore, this way of adopting security tests in every phase of app development will effectively help healthcare devices meet the required security requirements.

Challenge with Cloud Adoption:

Every healthcare enterprise of the present world is significantly shifting towards the Cloud. This way of shifting to the cloud is increasing challenges with respect to network and data security of these medical devices testing. If enterprises fail to overcome these challenges, then it might adversely affect their brand. Hence, to overcome these scenarios and to handle the evolving challenges, it is required for enterprises to adopt the practices of cloud application testing and security testing during data migration to ensure a more secure network and safety to cloud data. With trained QA resources from an independent testing services company, it becomes easy for businesses to embrace cloud


It is a known fact that medical devices are critical as they have a direct impact on patient’s healthcare. To ensure optimal working of medical devices an end-to-end medical device software testing is essential.

Any sort of performance issues prevailing in these devices proves to be fatal to the patient’s healthcare. Thus, to ensure fully-functional medical device software, businesses should adopt effective software quality assurance.

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