Risk control measures in medical device software

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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: medicaldevicehq.com/iec62304
Read more about risk control measures in medical device software here:
medicaldevicehq.com/risk-cont...
Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:
medicaldevicehq.com/introduct...
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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Опубликовано:

8 авг 2024

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Комментарии : 7

@jasa_m7990 3 года назад

Thank you! I' am a junior RM for medical device software and I must say this helped me clear a lot of confusion!

@christiankaestner6511 3 года назад

Awesome! Glad to hear it was helpful! Perhaps you also find this interesting: ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE--MoG7TFJBdI.html

@user-lv7bn1lh4t 11 месяцев назад

Very good content! My question is, according to IEC/TR 80002-1 content 'Estimates of probability of a HAZARDOUS SITUATION leading to HARM (P2) generally require clinical knowledge to distinguish between HAZARDOUS SITUATIONS where clinical practice would be likely to prevent HARM, and HAZARDOUS SITUATIONS that would be more likely to cause HARM.' Whether P2 can define a probability table like Po?

@tomwalet1372 2 года назад

First and foremost, thank you very much for the video (and the other videos), it makes things much clearer ! My question is, and I am not a software expert, the software architecture is built out of many software items : do we have to have a Hazard "Failure of software item" for each software item ? Thank you !

@christiankaestner6511 2 года назад

I'm glad you enjoy our videos! The short answer to your question is no. For example, if you have class A items, such items are not supposed to contribute to risk, and consequently, they should not be traceable to any hazard or hazardous situation. I suggest you rephrase the question: "What software item can contribute to a hazardous situation?"

@michaelk3163 2 года назад

Thanks for the video! Am I correct that RCMs must be outside the software they mitigate?

@christiankaestner6511 2 года назад

It depends... RCMs intended to lower your software safety classification must always be outside of the software system it mitigates. Once done with the classification, you are still expected to explore what RCMs you can implement inside your software system. The purpose of the internal RCMs is to do your utmost to reduce the likelihood of the software contributing to a hazardous situation.