significant risk

Is A Pacemaker A Significant Risk Device?

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Is A Pacemaker A Significant Risk Device? A pacemaker that is a modification of a commercially available pacemaker poses SR because the use of any pacemaker presents a potential for serious harm to the subjects. This is true even though the modified pacemaker may pose less risk, or only slightly greater risk, in comparison to

What Is A Significant Risk Device?

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What Is A Significant Risk Device? Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health. What is a high risk device? High-risk, or class III, devices — those which support or