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Help with Risk/Benefit Analysis Self-help Device for Diabetics



I am working at a small medtech company that develops a self-help device for diabetics. At the moment I am working with establishing the SOP for risk managment, in according with ISO 14971:2012. However, the risk/benefit analysis gives me some trouble. We should prove that the benefit outweighs the risks for all risks. Our consultant, who is a risk management expert, said that we need to write a motivation for every risk/benefit analysis. Since this work would be tedious if we take each risk separately, our risk management expert suggested that we should group the risks together according to certain parameters and then determine the benefit/risk for each group.

Acccording to what principles/criteria is it better to group one group risks together?

Has anyone in here been in a similar situation and/or has any suggestion about how to solve this?


This is only a suggestion and not one from experience as I generally write individual risk/benefit statements (definitely tedious!). Perhaps group risks according to the source of the hazard and then based on level of severity?
I will soon need to do one myself...
You can group the risks per user function or software/hardware subsystem.
Another suggestion I have for you is to document the risk / benefit statement in a meeting minuets rather than on the RMM file; it should be easier to handle it this way.

good luck,


I am trying to establish a process that would allow to perform also Risk Analysis on the complete System ( the final bündle of apps and components that the costumer will get ). However I am facing the isssue of how to maintain the risk Analysis, and more in General the risk Management file when dealing with different versioning of the components/apps.

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