Does Quality Matter in Medical Device Testing?

The role of medical Science in treating debilitating diseases and rising life expectancy has seen the use of diagnostics, vaccines, medications, and treatments like never before. In reality, as a result of the developments that have happened in the sphere of science – be it in technology, metallurgy, information technology, nanotechnology, genetics, bio chemistry, or atomic science, their connected effect was felt profoundly in the field of medicine also. The higher use of medical devices post finishing medical device software testing, whether employed for diagnostic or treatment purpose, has witnessed many spinoffs in the business. These may be seen in the kind of devices such as pacemakers, stents, incubators, ventilators, MRI and CT scan machines, or radiology devices. Importantly, the function of such devices supported by medical devices testing specialists is becoming crucial for medical professionals in selecting a particular treatment protocol.

Since the very Lives of individuals rely on the smooth functioning of these devices, the use of medical device testing has found increased salience. Moreover, Indian and international security standards like 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 specialists for their security and reliability.How the accuracy of Such devices can affect the lives of patients could be explained with two illustrations. If the ECG machine provides a ‘normal’ report for a patient an instance of non-invasive of medical device testing that has suffered a cardiac arrest, the specialist treating the individual may infer the pain as gastric in character consequently, threatening his very survival. Additionally, if a CT scan machine isn’t supported by medical devices testing specialists and releases radiation over the prescribed limit, it may place the lives of patients, physicians and staff in hazard.

Why QA is significant in medical device testing?

It ensures that the apparatus and its embedded applications works fine from the point of precision, responsiveness, functionality, and reliability.

• Prevents apparatus from malfunctioning especially during the conduct of critical medical procedures
• aids in the identification and treatment of disorders
• Enhances confidence of the medical professional in adopting a particular line of therapy
• Reduces risks particularly from radiation to the patient, staff and physicians
• Better devices imply lesser period of stay in hospital resulting in savings in price
• Aids in complying with recognized quality criteria
• Earmark responsibilities and scope of testing by medical devices testing specialists
• Identification of crucial parameters
• Select the inputs and related outcomes
• Establish the limitations of parameters
• Assess the function of each parameter in terms of its impact
• Identify glitches and work on them
• Conduct re-evaluation of the enhanced parameters