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„General documents/intended-use.md“ ändern

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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 ## Product
* Name: *\<product name\>* * Name: basebox
* Version: *\<product version\>* * Version: Applies to all versions
* Basic UDI-DI: *\<insert UDI-DI, if/when available\>* * Basic UDI-DI: Applicable for the medical device which integrates basebox.
## Intended Use ## Intended Use
> Describe the core medical functionality of your device and how it treats, diagnoses or alleviates a disease. > 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. > 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 ## Intended Medical Indication
> Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by N/A. See above.
> your software. Importantly, also list exclusion criteria: Maybe patients with a certain diagnosis should not
> be using your device.
## Contraindications ## Contraindications