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    • General aspects  
    • Device description           
    • Risk management file      
    • List of used harmonized standards
    • GSPR checklist
    • Performance
    • Electrical safety and EMC
    • Usability
    • Sterilization           
    • Packaging and shelf life   
    • Biocompatibility    
    • Clinical evaluation
    • Manufacturing information
    • Labeling    
    • Animal tissue        
    • Drug/device combinations
  • Software Safety Classification and rationale
  • Software version submitted
  • Software Requirement Specifications
  • Software Architecture description
  • Traceability between requirements and verification/validation activities
  • Verification / Validation plan
  • System level test reports
  • Verification and validation summary
  • Bugs or Defects including rationales
  • Release notes
  • Information how SOUP was validated
  • IEC62304 compliance report

...