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René Herzer 2023-02-17 09:25:34 +00:00
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General documents/intended-use.md
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@ -34,20 +34,19 @@
## Product
* Name: *\<product name\>*
* Version: *\<product version\>*
* Basic UDI-DI: *\<insert UDI-DI, if/when available\>*
* Name: basebox
* Version: Applies to all versions
* Basic UDI-DI: Applicable for the medical device which integrates basebox.
## Intended Use
> Describe the core medical functionality of your device and how it treats, diagnoses or alleviates a disease.
> Keep it high-level so that this description is true for as long as possible even when the device is updated.
The following characteristics of an intended use have to be defined by the medical device manufacturer using basebox.
## Intended Medical Indication
> Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by
> your software. Importantly, also list exclusion criteria: Maybe patients with a certain diagnosis should not
> be using your device.
N/A. See above.
## Contraindications