Medical device software risk management and IEC 62304 terminology
Автор: Medical Device HQ
Загружено: 2021-04-21
Просмотров: 9596
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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