Sven Jungmann
Real World Evidence (RWE) versus Real World Data (RWD)
Real-World Evidence (RWE) Real-world evidence (RWE) is a type of clinical evidence (i.e., gathered from observation and treatment of...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Cost-effective
The general definition of cost-effective concerns whether a product, process, solution, etc., saves or makes money when compared to the...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical harm
Clinical harm is unintended physical injury as a result of an adverse effect of medical care. This includes not only undesired reactions...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical Benefit
Similar to a word like “value,” clinical benefit can take on different meanings based on each stakeholders’ perspective. For the patient,...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Value
Defining value is not so easy because it can take on several meanings based on different perspectives within the healthcare ecosystem....
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Sven Jungmann
- Dec 26, 2021
- 1 min
Uncertainty
Uncertainty is defined as the “subjective perception of ignorance,” or simply put, “we know that we don’t know.” It is a constant in...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical evidence
Clinical evidence is a critical component of technical documentation for a product or device. It is generated by the clinical evaluation...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical evaluation
Clinical evaluation is a process undertaken by the manufacturer with both initial and ongoing/routine actions to substantiate the safety,...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical data
Clinical data is information regarding the performance, effectiveness, and/or safety of a medical product or device. This data is...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Intended use / intended purpose
Intended use or intended purpose refers to what a manufacturer intends their product to do or accomplish. In other words, what was the...
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Sven Jungmann
- Dec 26, 2021
- 2 min
Outcome-Action Pairing
Outcome-Action Pairing (OAP) is a term heard quite frequently when discussing AI solutions, so let’s break it down: Outcome = An output...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Disease burden
Disease burden quantifies the impact of a specific health condition by measuring the gap between the current health of a population and...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical study design
Clinical study design is the creation and development of medical experiments or trials for research involving humans. This also includes...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical Decision-Making
Clinical Decision-Making has been described as the “contextual, continuous and evolving process where data is gathered, interpreted and...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Clinical Trial
A clinical trial is a research procedure to investigate potential outcomes and effects of medical products, devices, and lifestyle...
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Sven Jungmann
- Dec 26, 2021
- 1 min
In Vitro Diagnostic (IVD) medical device
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...
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Sven Jungmann
- Dec 26, 2021
- 1 min
SaMD Changes
SaMD Changes, simply put, mean any modifications made throughout its lifecycle. This includes any modifications made during the...
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Sven Jungmann
- Dec 26, 2021
- 1 min
SaMD Manufacturer
The SaMD manufacturer is the person or entity (company or corporation) legally responsible for the design and/or manufacturing of a SaMD....
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Sven Jungmann
- Dec 26, 2021
- 1 min
Software as a Medical Device
“Software as a Medical Device,” or SaMD, refers to a software product that is intended for medical purposes but is independent from...
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Sven Jungmann
- Dec 26, 2021
- 1 min
Medical Device
A medical device is defined as any “instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,...
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