Medical device software risk management and IEC 62304 terminology
This is an excerpt from the course "Software for Medical Devices and IEC 62304" which is available at: https://medicaldevicehq.com/iec62304 Read more about software risk management and IEC 62304 terminology here: https://medicaldevicehq.com/medical-d... Don't miss checking out the online course SaMD, IEC 62304 and IEC 82304-1: https://medicaldevicehq.com/introduct... Chapters: 00:00 Introduction 00:15 About the instructor 00:40 Understanding risk management 1:19 Risk according to ISO 14971 2:10 Hazard 2:57 Sequence of events 4:45 Hazardous situation 5:14 Harm 5:56 How to estimate the risk 6:22 Probability of the occurrence of harm (Po) 7:30 Calculating Po 8:21 Evaluation matrix 9:06 Risk control measures 9:43 Po in software 11:24 The importance of P1 and P2 11:51 Additional resources
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