Risk Management for Medical Device - Virtual Course

OUTLINE (Return to Main)

• Summaries of risk management processes
  • Risk management
  • Fault tree analysis (FTA)
  • Failure mode and effects analysis (FMEA)
  • Process mapping
  • Hazard analysis and critical control point (HACCP)
  • Human factors
  • Software safety
• Example templates
• Summary

Percentage of Time Spent on Main Topics

• Discuss some important regulatory and ancillary topics
  • 80% - 90%
• During direct topic discussion, time will be divided
  • 60% Lectures
  • 40% Workshops

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