Risikomanagement für Medizinprodukte-Software nach ISO 14971

Medical Device

7/22/2022

• Foundations of risk management
• Risk management process acc. to ISO 14971
• Differences between ISO 14971:2019 and ISO 14971:2012
• EU harmonization of ISO 14971:2019
• Risk management analysis
• Hazards and hazardous situations
• Risk management documentation
• Risk management evaluation
• Risk matrix with likelihood of occurrence and severity of risk
• Risk management planning
• Root cause analysis
• Failure Mode Effects Analysis, Fault Tree Analysis
• Preliminary Hazard Analysis
• Typical software fault patterns
• IT security
• Guidance from TIR24971-2020
• Guidance from IEC/TR 80002-1
• Risk management reporting

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