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  • bb254 replied to the topic Significant risk vs Non-significant Risk in the forum Clinical Trials for Medical Devices 6 years, 11 months ago

    The first medical product that comes to mind when I heard of significant risk is a pacemaker. It is an implant which contains an electrical circuit that sends electrical impulses to the heart. My father has a pacemaker and it has so many benefits, but it does propose a health risk. A pacemaker takes the role of the SA node within the electrical system of the heart. It is a class III medical device and can cause harm to a patient due to the fact that it is implanted. A non-significant risk medical product is a tongue depressor. Its not implantable, it doesn’t propose any serious health risk to the user. It doesn’t place the well-being of the user at risk. A tongue depressor is a class I medical device which doesn’t create any electrical simulation directed toward the heart.