Objective 4.2
Manufacturer shall apply a risk management process compliant with ISO 14971.
Main Description
Related elements:
Perform Safety and Reliability Analysis
Update Dependability Analysis
Failure Modes and Effect Analysis
Fault-Tree Analysis
Hazard Analysis
Safety Czar
Reliability Czar
Fault Tree Analysis
Hazard Analysis Guideline
More information:
Practice: Safety and Reliability Analysis
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