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Technical Documentation

Checklist

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 Checklist
  Table of contents
  - Annex D: Change History
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

General Safety and Performance Requirements (GSPR)¶

MDR Annex I Checklist

Requirement	Applicable	Method of Conformity	Reference
1. Devices shall achieve the performance intended...	Yes	Testing	50.01
...	...	...	...

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