What You Should Know About The Medical Devices Testing?


Due to the extreme relentless virus, COVID-19, which affects millions of people around the globe, the planet has never thought of such a huge catastrophe. This is an extraordinary condition in human history that has spread quickly and rampantly from one part of the world to another. 

This current coronavirus pandemic has expanded to more than 210 countries around the world, triggering a mere lockdown of the professions, habits, and livelihoods of people, with an overarching need to preserve social distance and explain the need for more knowledge of health.

Besides, with the ever-growing occurrence of cases of Coronavirus outbreak, healthcare stakeholders around the world are looking for resources and drugs to help quickly stop the spread of this unpredictable tide of disease.

Doubtlessly, every business sector is affected by the Covid 19 epidemic in various ways, but healthcare is at the forefront with rising demand for medical devices and healthcare testing services growing more pressure from all means worldwide with less supply all around.

It is a gaze-striking fact that, when thousands are infected by the virus within a few months of the coronavirus outbreak, it results in a scarcity of medical equipment and medical devices. The need for the hour to save millions of lives is fundamentally successful and high-quality medical devices as critical cases affected by coronavirus continue to rise worldwide.

Cardiovascular, ophthalmic, infusion pumps, clinical electronic thermometers, respirators, ventilators and accessories, remote surveillance systems, devices for numerous medical techniques, etc., are some of the most critical medical devices as listed by the FDA.

Medical equipment is important as they have a direct effect on the survival of human life as the readings they demonstrate to have a huge effect on the direction of care offered to individuals. The accessibility of medical devices should mainly be smooth and should yield flawless results.

The FDA is also responsible for monitoring the safety and efficacy of medical devices, particularly mobile medical applications, and has recently listed several policies for public health.

In these pandemic times, if these vital medical devices software does not work well, then it poses a great risk to the well-being of the patient.

Therefore, medical device software testing is essential to function effectively and to ensure adequate testing figures while tests are carried out on people using these devices.

These devices should therefore perform seamlessly and should be fully functional to ensure proper test results, particularly during these pandemic periods. They should be rigorously tested to ensure proper functioning and repairs of these devices to achieve effective software operation of these medical devices.

Software Testing Types in Medical devices testing:

The following elements must constitute a testing framework for applications for medical devices testing of all levels of concern:

1. Validating software

Begin by validating software specifications and ensuring that the software based on these requirements is compatible with and usable in its intended use.

2. Verification of Software Specifications

As the next step, I suggest checking the consistency of specifications to identify possible software defects at the earliest software life cycle stages. Examination of software features, efficiency, protection, and other criteria for transparency, accuracy, and traceability.

3. Verification of Device Designs

Involve a software architect to verify that the software architecture meets the specifications sufficiently, meets the applicable safety standards, and is designed to mitigate quality risks. The QA team, in turn, should search for consistency and unambiguity in the software design specification. While at least one formal design review carried out at the software design stage is required by the FDA, I suggest incorporating design verification at the end of each life cycle stage of the software.

4. Reviews of code and checking of units

Here it is suggested to set up protocols that make it easier to identify defects earlier in the life cycle of software development. Implement code quality guidelines to assess consistency, complexity, maintainability, and other related aspects of the specifications. To verify its compliance with the agreed standards, conduct a source code analysis and develop periodic code reviews as part of software coding practice.

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It is also beneficial to increase the share of testing done at the unit level by the production team as it helps to detect defects at the stage that they are substantially simpler and less costly to repair.

5. Verification for software

Medical device and software manufacturers are frequently forced to rapidly-produce quality software, but it is not possible to limit medical device software testing to a bare minimum. Thus, I suggest merging testing at the API level with testing at the device level, accompanied by rigorous regression testing, to optimize the test process while impacting software quality. Also, consider implementing such established activities within a CI / CD pipeline as test automation and continuous testing applied.

The non-functional features of applications for medical devices often have to be extensively validated. Therefore, with efficiency, usability, protection, and compatibility testing, here is the recommended accompanying testing process.

6. Verification of Compliance

For example, if a medical device is subject to a compliance review, it must be checked to comply with the regulations demanded by ISO 13485, IEC 62304, or IEC 82304-1, adding assurance of compliance to the scope of verification activities.

  1. To ensure that medical devices are defect-free and can be used for monitoring and treating patients, end-to-end medical device usability testing should be taken up.
  2. Based on applicable requirements, medical devices should be checked for compliance.
  3. As user experience and consumer reviews usually prove to be a key factor that can decide the success of an entire product, the user interface of medical devices should be checked.

With the ongoing pandemic attacks across the globe, this is a crucial time when healthcare and medical equipment must operate smoothly at this hour. These medical devices can perform well and provide accurate patient readings when paired with other devices.

Therefore, to obtain reliable medical devices testing results for devices and to operate properly, medical device software must perform well under all conditions. For each element, medical devices testing should be checked and should be fully functional.

Hope now you know all about medical device testing!!