Medical device software risk management can be a challenge! In this video, you will not only learn about the difference between “software risk control” and “risk control measures implemented by software”, you will also learn about where to look for potential software causes contributing to hazardous situations. And finally, how to document software risks, causes and measures.

This is an excerpt from the course "Introduction to Software for Medical Devices and IEC 62304" which is available at: [ Ссылка ]

Read more about risk control measures in medical device software here:
[ Ссылка ]

Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:
[ Ссылка ]

Chapters:
0:00 Introduction
0:17 About the author
0:42 Reasons for confusion in software risk management
1:23 Software risk controls vs. risk controls implemented by software
3:18 Probability of software failure
4:46 P1
5:40 Identifying potential causes for software failures
6:41 Development process
7:14 Software system
8:00 Software items
8:30 Risk controls
9:27 Hazard traceability matrix
11:42 Calculating Po
12:19 Evaluation matrix
12:52 Risk control options analysis
14:27 Additional resources

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