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Technical Documentation

Plan

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 Plan
  Table of contents
  - 1. Reactive Surveillance
  - 2. Proactive Surveillance
    
    Annex D: Change History
- Report
Changelog

Post Market Surveillance Plan (PMS Plan)¶

MDR Annex III

1. Reactive Surveillance¶

Complaints handling
Vigilance reporting

2. Proactive Surveillance¶

Surveys
Literature reviews
PMCF (Post Market Clinical Follow-up)

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