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Biological and clinical evaluation

Biological evaluation is a ”must” for all devices with direct or indirect contact with the patient.

About Biological and Clinical Evaluation

Biological evaluation is a ”must” for all devices with direct or indirect contact with the patient. As regulatory demands increase, it is important to understand early in the development process what the requirements are.

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Clinical evaluation is another ”must” for all medical devices regardless of device classification. A clinical evaluation is the assessment and analysis of clinical data needed to verify the clinical safety and performance of the device.

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