Create USI

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	21.03.2014 10:35:32
Modified:	16.09.2019 14:50:04

Diagram Elements :

Specify user profile

Do mental walk through

Consider PRS

Device Hazard Analysis (DHA)

Specify and consider primary functions and operating principle

Consider clinical data

Clinical evaluation plan

IEC 62366 Usability

Consider and follow the IEC 62366 requirements and scale the usability efforts

Product Manager

USI specified

Preliminary review of user interface concept

Evaluate "Things that can go wrong"

Use case analysis (proposed activity)

Create activity / task analysis (proposed activity)

Specify use scenarios

Consider reported AEs and clinical trends

AE surveillance report

Consider market and competitor information

Market research report

Intended product development

Product Requirement Specifications (PRS)

Specify and refine intended use

Usability Specification Inputs (USI)