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Uncertainty is defined as the “subjective perception of ignorance,” or simply put, “we know that we don’t know.” It is a constant in...

Clinical evidence is a critical component of technical documentation for a product or device. It is generated by the clinical evaluation...

Clinical evaluation is a process undertaken by the manufacturer with both initial and ongoing/routine actions to substantiate the safety,...

Clinical data is information regarding the performance, effectiveness, and/or safety of a medical product or device. This data is...

Intended use or intended purpose refers to what a manufacturer intends their product to do or accomplish. In other words, what was the...

Outcome-Action Pairing (OAP) is a term heard quite frequently when discussing AI solutions, so let’s break it down: Outcome = An output...