Importance of QA in Medical Device Testing

The role of medical science in treating debilitating diseases and increasing life expectancy has seen the use of diagnostics, vaccines, medicines, and therapies like never before. In fact, thanks to the developments that have taken place in the field of science - be it in engineering, metallurgy, information technology, nanotechnology, genetics, bio chemistry, or nuclear science, their connected impact was felt profoundly in the field of medicine as well. The increased use of medical devices (post completing medical device software testing), whether used for diagnostic or treatment purpose, has seen many spinoffs from the industry. These can be seen in the form of devices like pacemakers, stents, incubators, ventilators, MRI & CT scan machines, or radiology devices. Importantly, the role of such devices (validated by medical devices testing experts) has become crucial for medical practitioners in choosing a specific treatment protocol.

Since the very lives of people depend on the smooth functioning of such devices, the role of medical device testing has found increased salience. Moreover, international and Indian safety standards such as US FDA CFR Title 21 Part 11, ISO 14971, ISO 9000, and IEC 62304 mandate such devices to be rigorously tested by medical devices testing experts for their safety and reliability.

How the accuracy of such devices can impact the lives of patients can be explained with two examples. If the ECG machine delivers a ‘normal’ report for a patient (a case of non-compliance of medical device testing) who has suffered a cardiac arrest, the specialist treating the patient can infer the pain as gastric in nature thereby, threatening his very survival. Also, if a CT scan machine is not validated by medical devices testing experts and releases radiation more than the prescribed limit, it can put the lives of patients, doctors and staff in peril.

Why QA is important in medical device testing?

• It ensures that the device and its embedded software works fine from the point of accuracy, responsiveness, performance, and reliability
• Prevents devices from malfunctioning especially during the conduct of critical medical procedures
• Aids in the diagnosis and treatment of ailments
• Enhances confidence of the medical specialist in adopting a particular line of treatment
• Reduces risks especially from radiation for the patient, staff and doctors
• Better devices mean lesser period of stay in hospital leading to savings in cost
• Helps in complying with established quality standards

How to go about carrying out medical device software testing?

• Earmark responsibilities and scope of testing by medical devices testing experts
• Identification of crucial parameters
• Select the inputs and related outcomes
• Set the limits of parameters
• Evaluate the function of each parameter in terms of its impact
• Identify glitches and work on them
• Conduct re assessment of the improved parameters
• Document the same

In fact, with the advent of embedded software in medical devices, their smooth functioning has become critical from the point of view of securing the lives of patients. If a crucial part of such software happens to contain a bug, it could result in giving erroneous results or worse lead the device to malfunction altogether. Thus, validation of such software by medical devices testing experts encompasses the entire end to end medical device software testing and development life cycle.

Conclusion

Medical device software testing can mean the difference between patients getting a new lease of life or suffering consequences including the loss of lives.

Michael works for Cigniti Technologies, which is the world's first Independent Software Testing Company to be appraised at CMMI-SVC Level 5, and an ISO 9001:2008 & ISO 27001:2013 certified organization.