This is an excerpt from the course /"Introduction to Medical Device Software and IEC 62304/" available at: https://medicaldevicehq.com/iec62304

Read more about software risk management and IEC 62304 terminology here:
https://medicaldevicehq.com/medical-device-software-risk-management-iec-62304/

Don't miss the Introduction to SaMD and IEC 82304-1 online course:
https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/

Chapters:
00:00 Introduction
00:15 About the instructor
00:40 Understanding risk management
1:19 Risk according to ISO 14971
2:10 Danger
2:57 Sequence of events
4:45 Dangerous situation
5:14 Damage
5:56 How to assess risk
6:22 Probability of damage occurring (Po)
7:30 Calculate 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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