Fda Classification Class Ii Medical Devices Overview

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Why Design Matters in Medical Software Development


Software development can happen very quickly. Software developers can make improvements and enhancements to software easily without the need for physical products. Medical devices have not historically been products that iterate very quickly. Largely, this is because of design controls. A manufacturer must identify the needs of their medical device and the medical device must […]

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FDA Classification: Class II Medical Devices Overview


The FDA regulates medical devices by their risk level and each medical device fits into one of three classes. Class I are medical devices that have the least risk to the patient and Class III are the most risky medical devices. However, roughly 50% of all US medical devices are regulated as class II medical […]

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