Skip to content

Technical Documentation

Report

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
- 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 Report
  Table of contents
  - Data Analysis
  - Conclusion
    
    Annex D: Change History
Changelog

Post Market Surveillance Report¶

MDR Article 85 (Class I) / PSUR Article 86 (Class IIa/IIb/III)

Data Analysis¶

...

Conclusion¶

...

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