Risk control measures in medical device software

[@jasa_m7990]

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

[@christiankaestner6511]

Awesome! Glad to hear it was helpful! Perhaps you also find this interesting: kzbin.info/www/bejne/Y37SeGqKe691mqs

[@michaelk3163]

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

[@christiankaestner6511]

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.

[@Cecilia-y6h]

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]

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]

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?"