Good afternoon,
My problem/doubt is the following:
We have a medical device ( I will call it System) which is composed by different sub-systems, which are also medical devices.
Each sub-system can be seen as an indipendent product (Software in most cases) which comes with its own risk management plan and risk acceptability matrix and criteria.
The System is looking at the integration of these sub-systems and also for the System a risk matrix, with related risk acceptability criteria, is defined.
My doubt is the following: how to handle at system level different acceptability criteria that might come from different sub-units?
My guts tell me that we always have to consider the most critical acceptability level but I am not sure if this is right.
I believe that the scale of probability and severity should not change , because the probability is always a number from zero to one and should have the same meaning for all the products. However, I wonder how different level of acceptability criteria for two risks that are rated with same P and S can be assessed.
Do you have any experience or suggestion in how such cases could be handled?
Thanks so much for your help!
My problem/doubt is the following:
We have a medical device ( I will call it System) which is composed by different sub-systems, which are also medical devices.
Each sub-system can be seen as an indipendent product (Software in most cases) which comes with its own risk management plan and risk acceptability matrix and criteria.
The System is looking at the integration of these sub-systems and also for the System a risk matrix, with related risk acceptability criteria, is defined.
My doubt is the following: how to handle at system level different acceptability criteria that might come from different sub-units?

My guts tell me that we always have to consider the most critical acceptability level but I am not sure if this is right.
I believe that the scale of probability and severity should not change , because the probability is always a number from zero to one and should have the same meaning for all the products. However, I wonder how different level of acceptability criteria for two risks that are rated with same P and S can be assessed.
Do you have any experience or suggestion in how such cases could be handled?
Thanks so much for your help!