Why is Quality Assurance needed for Medical Devices?

Medical devices have become the backbone of the healthcare industry as they help healthcare professionals diagnose conditions or ailments and treat patients. These devices have reduced the probability of ‘assumption or chance’ in diagnosis and added a modicum of certainty. Just think of a doctor making a correct diagnosis of a patient’s illness after thoughtfully studying the MRI scan report instead of merely going by the symptoms. Also, medical devices have greatly facilitated the functioning of telemedicine during the pandemic and allowed healthcare professionals to treat patients virtually.

This way, many patients were spared the ordeal of visiting overcrowded hospitals or healthcare facilities and contracting the virus. And to ensure the effectiveness of such devices and meet the rigorous regulatory standards, manufacturers are implementing quality assurance. According to markets and markets, the global medical device software testing market is likely to touch $11.8 billion by 2025, at a CAGR of 4.8 percent. The driving factors for growth in testing medical devices are:

l Harmonization of regulatory and quality standards

l Growing usage of medical devices across the world

l Growing need for verification and validation of medical devices

l Application of stringent government and industry regulations

l Outsourcing QA medical devices to a medical device testing company

Since medical devices have a direct impact on the lives of patients, they need to be tested rigorously on all parameters, including adhering to regulatory standards such as ISO 13845:2016. Medical devices bring with them a high level of responsibility and liability on the part of the manufacturers. As the technology and processes have become highly complex, the quality of medical equipment testing services needs the implementation of an automated quality management system.

What are QA medical devices all about?

Given the critical role of medical devices in the healthcare domain, they are highly regulated by a multitude of regulatory bodies. Further, they need to meet a set of standardizations and compliances and deliver accurate readings, effective performances, and safety. For instance, a CT scan should not emit harmful X-ray radiation beyond the safety limits, and the probes comprising electrodes for EEG should be safe to record the electrical impulses of the brain. To ensure these, there should be a proper strategy for medical devices validation in place. Medical device software testing ensures the device’s software and systems are fully compliant and compatible with various regulatory frameworks.

What is the importance of testing medical devices?

The benefits of applying QA to ensure medical devices validation are as follows:

l Upholds quality compliance with various regulatory frameworks and standardizations including HIPAA, FDA, and PCI DSS, among others.

l Ensures various components of medical devices, such as CRMs, software, and database management systems, among many others, function seamlessly under different scenarios.

l Proper connectivity of medical devices with third-party tools can be verified and validated using integration testing.

l Helps to enhance the clinical efficiency and effectiveness of medical devices.

l Ensures superior patient experiences and optimal patient care.

l Eliminating or mitigating any risk of failure by implementing end-to-end medical device software validation.

l Identifies and fixes glitches that can otherwise lead to false diagnoses.

l Reduces market time for medical devices.

l Elimination of wasteful and non-value-added activities.

How to mitigate the future risks associated with medical device software testing?

It is not only about mitigating the present risks but also anticipating and securing the devices against potential risks in the future.

Cybersecurity concerns: With the integration of medical devices into cloud platforms, there is an increased risk of cybersecurity concerns. For instance, threat actors can break into medical devices and cause them to malfunction or give erroneous results. To avoid such situations, the FDA is coming up with a pre-market regulation wherein manufacturers of such devices will have to incorporate stringent data safety measures. Besides, manufacturers will be required to submit a ‘software bill of material’ to validate product information for customers.

Promoting innovation: With smart technologies on the anvil, medical devices need to incorporate them to improve efficiency, usability, accuracy, and safety. These technologies have the vast potential to be deployed across the healthcare ecosystem. The new-gen technologies can facilitate device upgrades and automation with respect to factors such as accessibility, operation, and safety. However, not everything is hunky-dory with these next-gen technologies, for there can be complications as well. These relate to the sharing of data in the cloud and the integration of apps with medical devices. Remember, the effectiveness and sustainability of medical devices are directly proportional to the integrity of the data they offer. This is where the FDA is contemplating ways to build streamlined pathways to mitigate risks and enhance the quality of medical devices in the future.

Conclusion

Quality assurance in medical devices testing verifies whether the procedures and processes are compliant with regulatory standards such as ISO 13485:2016, MDSAP, or USFDA. It verifies facets such as medical device design, supplier management, risk management, clinical data, product labeling, complaint handling, and storage and distribution, among others.

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.