Radiotherapy AI

  • Radiotherapy AI’s QMS and TechDoc
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  • Classifications and Regulatory Checklists
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    • User Manual [enter Product Name]
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      • Failure Mode and Effects Analysis (FMEA): Risk Acceptance Matrix
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    • 62366
      • IEC 62366-1:2015 Mapping of Requirements to Documents
      • List of Hazard-Related Use Scenarios
      • Usability Evaluation Plan
      • Usability Evaluation Protocol
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Contents
  • Mapping of Standard Requirements to Document Sections
  • Summary
  • 1. Hazard-Related Use Scenarios

List of Hazard-Related Use Scenarios

Contents

  • Mapping of Standard Requirements to Document Sections
  • Summary
  • 1. Hazard-Related Use Scenarios

List of Hazard-Related Use Scenarios#

Mapping of Standard Requirements to Document Sections#

IEC 62366-1:2015 Section

Title

Document Section

5.4

Identify and describe Hazard-Related Use Scenarios

1

5.5

Select the Hazard-Related Use Scenarios for Summative Evaluation

1

Summary#

The goal of the list of Hazard-Related Use Scenarios is to gather all Use Scenarios which could be associated with a Hazard, e.g., if a user doesn’t understand a certain feature of the app (bad design leading to poor usability), then a Hazard could be encountered which could subsequently lead to a Hazardous Situation.

1. Hazard-Related Use Scenarios#

Fill out this list with Use Scenarios which could be Hazard-related. A good rule of thumb is to have 3-10 scenarios, based on the risk profile of your software.

Also, note that you should prefer to create a spreadsheet for this table (e.g., in Google Sheets) as putting a table in a document will surely lead to chaos. But then again, there’s always a certain level of chaos in regulatory documentation.

ID

User Group

Description

App State / Environment

Tasks

Acceptance Criteria

1

Physician

Assess COVID score

1) App is installed
2) App displays patient result

Understand COVID score and initiate further medical treatment

COVID score is understood correctly

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Usability Evaluation Plan

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