ROLE AND METHODS FOLLOWED BY QUALITY ASSURANCE IN MEDICAL DEVICE TESTING

QUALITY ASSURANCE IN MEDICAL DEVICE TESTING

 

India is one of the top global markets for medical devices. In 2020, the medical devices market valued Rs. 77,539 and is expected to reach Rs. 352,450 in 2025. It is increasing at a 3.5% CAGR.

The growing acceptance of research, new technology, and the development sector is driving the market. About 800 domestic manufacturers and an average of 19,170 million are invested, with a turnover of about 700 crore rupees.

Medical devices have to satisfy certain standardizations and compliances. Furthermore, they should provide compelling performance, precise readings and should be very safe while using it. Therefore, proper medical device testing is essential for medical devices.

The approach includes a planned software testing strategy and maintaining compliance procedures to bring device effectiveness.

Medical device testing ensures that products’ devices and software are fully compliant and compatible, along with several functionalities and regulations. This testing also ensures that these devices satisfy all quality-related features successfully, for which quality assurance plays a crucial role.

Thus, the manufacturers are required to adopt quality assurance for medical devices through validation and verification. It ensures the reliability and good quality of these devices.

Role of quality assurance in medical devices testing

Quality assurance assures compliance testing with several regulations like FDA, HIPAA, AND PCI DSS. It makes sure that medical device software, healthcare CRMs, patient database management systems, and patient mobile apps work flawlessly under different scenarios.

Moreover, integration testing of medical devices ensures good connectivity with other devices. Quality assurance also helps in improving the clinical efficacy of medical devices. To offer optimal patient care, proper and adequate testing is done to ensure various medical devices’ effectiveness and quality.

The risks of device failure are very minimal because of end-to-end device testing. Glitches in device software might result in a false diagnosis, and so quality assurance is vital to assure good performance and functioning of medical devices.

Methods followed by quality assurance for medical device testing

An effective testing approach aids to achieve efficacious device testing that is based on various sets of necessities. These requirements or necessities are based on several manufacturing procedures, component specifications, and some other functional specifications of the medical devices and software.

Proper assessment of the sets of essentials smoothens the test executions since tests can be performed effectively on the software. There are different methods involved in medical device software testing as follows.

  1. Functionality testing

It aims to test efforts to check how the device is expected to work under different scenarios. It includes the actual procedure of validating the devices. All the functions are thoroughly tested separately with a combination of parametric values to know the devices’ functionality.

  1. Device verification testing

This procedure ensures whether the evaluation of any objective proof with specified necessities of the device has been satisfied. This procedure initiates with well-defined and clear-cut product requirements which should be measured to verify them.

This process follows particular protocols and utilizes a standard methodology that correlates present product requirements with previously approved requirements. If the device verification procedure fails, it is necessary to undergo an investigation to learn the requirement that couldn’t satisfy the expectation.

Also, a further investigation will aid in sorting out if the requirement needs to be updated or not. An excellent medical device strategy can save a considerable amount of money for the enterprises and ensure the device satisfies the expectations with the least risks and lessened testing time.

  1. Device error detecting and compatibility testing

The device’s compatibility over various other devices has to be tested to prove its success. It is significant to test how the medical device responds or works under different error conditions, particularly under power fluctuations, internal defects, or peripheral device defects. The device must be able to deliver proper error alerts to notify users.

  1. Device validation testing

When the whole system is in place, the hardware and software of the devices must be validated.

The chief purpose of this process is to test if the medical device satisfies specific user needs. Unit testing is the early approach that is practiced by completing a set of stages in the process. Afterward, the whole system is validated all at once.

  1. Automated testing

This testing process makes the testing process more straightforward and overcomes manual functions to confirm quality at speed. It makes the quality assurance process more precise, complete, and faster.

Initially, the process involves stimulating the target device, observing the device response, keeping the entire process in control using automation, recording and declaring results.

  1. White-box testing

The essential part of testing is the automation of white-box testing. It ensures that the testing processes are closer to the coding stages of the project. Tests are done to monitor several parts to observe any overflow conditions, fault counts, timing interactions, and others.

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