From 3138ea821c4f50cb8893af0c39e48b7fc7931e25 Mon Sep 17 00:00:00 2001 From: =?UTF-8?q?Ren=C3=A9=20Herzer?= Date: Fri, 17 Feb 2023 09:25:34 +0000 Subject: [PATCH] =?UTF-8?q?=E2=80=9EGeneral=20documents/intended-use.md?= =?UTF-8?q?=E2=80=9C=20=C3=A4ndern?= MIME-Version: 1.0 Content-Type: text/plain; charset=UTF-8 Content-Transfer-Encoding: 8bit --- General documents/intended-use.md | 11 +++++------ 1 file changed, 5 insertions(+), 6 deletions(-) diff --git a/General documents/intended-use.md b/General documents/intended-use.md index c185629..a3bd130 100644 --- a/General documents/intended-use.md +++ b/General documents/intended-use.md @@ -34,20 +34,19 @@ ## Product - * Name: *\* - * Version: *\* - * Basic UDI-DI: *\* + * 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