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Real-World Evidence (RWE) Real-world evidence (RWE) is a type of clinical evidence (i.e., gathered from observation and treatment of...

The general definition of cost-effective concerns whether a product, process, solution, etc., saves or makes money when compared to the...

Clinical harm is unintended physical injury as a result of an adverse effect of medical care. This includes not only undesired reactions...

Similar to a word like “value,” clinical benefit can take on different meanings based on each stakeholders’ perspective. For the patient,...

Defining value is not so easy because it can take on several meanings based on different perspectives within the healthcare ecosystem....

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...

Disease burden quantifies the impact of a specific health condition by measuring the gap between the current health of a population and...

Clinical study design is the creation and development of medical experiments or trials for research involving humans. This also includes...

Clinical Decision-Making has been described as the “contextual, continuous and evolving process where data is gathered, interpreted and...

A clinical trial is a research procedure to investigate potential outcomes and effects of medical products, devices, and lifestyle...

First off, let’s define, “in vitro.” This term refers to where a process takes place: in a culture dish; a test tube (e.g., in-vitro...

SaMD Changes, simply put, mean any modifications made throughout its lifecycle. This includes any modifications made during the...

The SaMD manufacturer is the person or entity (company or corporation) legally responsible for the design and/or manufacturing of a SaMD....

“Software as a Medical Device,” or SaMD, refers to a software product that is intended for medical purposes but is independent from...

A medical device is defined as any “instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,...