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The Importance Of Performance Testing In Certifying Medical Devices

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By Author: Michael Wade
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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.

For example, in imaging devices such as CT scan and X Ray machines, the level of radiation released should be strictly set according to the specifications laid down by IEC or else, patients can suffer irreparable damage on account of radiation exposure. Also, devices for testing blood, sugar, heart rate, etc. should give accurate results or else, the line of treatment or dosage of medicines prescribed by physicians can go horribly wrong, severely impairing the health of patients.

Why Testing?
• To meet regulatory requirements and safety standards
• To test the efficacy and safety of devices
• To incorporate testing in the designing phase to absorb emerging technologies

The mechanics of Performance Testing of Medical Devices - an overview
Pre design phase: Here, conformation to regulatory norms, testing methodology, risk assessment and setting up of measurable deliverables are finalised.

Design phase: Here, test scripts are readied, SOPs for testing are finalised, inputs for designing are accounted for, followed by finalizing validation protocols and client sign off.
Deployment phase: Here, actual test is carried out, defects are logged and brought to the notice of development team, followed by final verification and validation.

To ensure objectivity, meeting standards and transparency, Medical device Testing should be carried out by Medical devices testing specialists, preferably from a reputed testing organisation. The reasons are:

• Specialised testing equipments are costly thus not needed to be set up in house.
• Medical devices testing experts are well-versed with compliance and regulatory standards or upcoming changes (if any).
• Medical device testing is a specialized discipline on its own that requires experienced human resources to deal with it.
• Carries greater credibility in the market.

Michael works for Gallop Solutions, which is North America's largest Independent Software Testing Services & company operating since 2003 with offices in Philadelphia & California.

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