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Compliance In Focus
Posted by John Lehmann on Tue, Oct 18, 2016

A Handy Guide to Medical Device Classifications

medical_device_classification.jpgA clinical trial is required for all new drugs, but this is not the case for all medical devices. Medical devices start by undergoing a risk assessment in order to determine the severity of potential harm to the user and the probability of that harm occurring. Each device is assigned to one of three classes based on this assessment, and this classification dictates whether or not a clinical trial is necessary.

Use the infographic below as a helpful resource for understanding medical device classifications.

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Conducting Global Clinical Trials

Topics: Medical Devices

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