Performance Testing as critical to medical devices testing


The advancements in medical science have brought about a revolution in the diagnosis and treatment of critical diseases. And an important cog in the wheel in the entire cycle of diagnosis and treatment is the suite of medical devices that is as varied in its range as the types of existing diseases.

Be it the drug eluting stents, magnetic resonance imaging machines, CT scan machines, X ray and ultrasound devices, Color Doppler, ECG or the pacemakers, the lives of patients depend upon the efficacy of these devices. Any malfunction in the functioning or performance of medical devices can have a serious impact on the condition of patients threatening even their very survival.

No wonder, the domain of Medical Device Testing has become so critical in the overall scheme of things. As embedded software is increasingly becoming the norm in new medical devices, they should be thoroughly checked – right from the design stage to the entire end to end development cycle.

Medical devices testing specialists should conduct performance testing on medical devices along with other tests to ensure they pass muster on regulatory requirements as well as during crucial clinical trials.

The role of medical devices in spheres of diagnosis and treatment of diseases has grown over the years. Moreover, the devices have undergone changes in terms of materials used, embedded software deployment, automation, and the way they capture crucial parameters related to the diagnosis and treatment of medical conditions.

As medical devices become crucial, the significance of Medical Device Testing has received increased traction amongst stakeholders. It is about increasing use of technology for designing, building, testing and deployment of medical devices.

Apart from meeting design specifications, medical devices have to be compliant with the standards set by federal and international regulatory bodies. Medical Device testing specialists have their tasks cut out when they check medical devices for robustness, accuracy, usability, safety and responsiveness a la performance testing.

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