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Technical Documentation

File

Technical Documentation

Overview
10 Device & Specification
10 Device & Specification
20 Risk Management
20 Risk Management
- File
- Plan
- Analysis
- Evaluation
30 Software Lifecycle (IEC 62304)
30 Software Lifecycle (IEC 62304)
40 GSPR (MDR Annex I)
40 GSPR (MDR Annex I)
- Checklist
50 Verification & Validation
50 Verification & Validation
- Verification Plan
- Validation Plan
60 Usability Engineering (IEC 62366)
60 Usability Engineering (IEC 62366)
- File File
  Table of contents
- Specification
70 Clinical Evaluation (MDR Annex XIV)
70 Clinical Evaluation (MDR Annex XIV)
- Plan (CEP)
- Report (CER)
80 Post Market Surveillance (MDR Annex III)
80 Post Market Surveillance (MDR Annex III)
- Plan
- Report
Changelog

Usability Engineering File¶

IEC 62366-1 Compliance

1. Use Specification¶

Intended Medical Indication
Intended Patient Population
Intended User Profile
Use Environment

2. User Interface Specification¶

See Usability Specification.

3. Formative Evaluation¶

...

4. Summative Evaluation¶

...

Annex D: Change History¶

Date	Version	Author	Changes
19. November 2025	1.1.0	Unbekannt	Automatische Metadatenaktualisierung
17. November 2025	1.0.1	Unbekannt	Automatische Metadatenaktualisierung