Following information is part of the intended use according to DIN EN ISO 13485:2016-08, Annex II, 1.1 c and , /wiki/spaces/QA/pages/176685192 , 5.2.
Intended Medical Indication
<Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by your software.>
Contraindication
<List exclusion criteria: Maybe patients with a certain diagnosis should not be using your device.>
Patient Population
<e.g. age groups (adults, children,adolescent, elderly), gender (male, female) or disease state>