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Technical Documentation

Evaluation

Technical Documentation

Overview
10 Device & Specification
10 Device & Specification
20 Risk Management
20 Risk Management
- File
- Plan
- Analysis
- Evaluation Evaluation
  Table of contents
  - Annexes
    
    Annex A: Change History
    
    See also
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
- 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

Risk Evaluation Report¶

This report summarizes the evaluation of risks following implementation of risk control measures. (Placeholder content)

Annexes¶

Annex A: Change History¶

Date	Version	Author	Changes
19. November 2025	0.1.0	Unbekannt	Automatische Metadatenaktualisierung
17. November 2025	0.0.1	Unbekannt	Automatische Metadatenaktualisierung

See also¶

Overview: Risk Management File — 20.01_risk_management_file.md
Risk Management Plan: 20.02_risk_management_plan.md
Risk Analysis: 20.03_risk_analysis.md