I have a probleme and need your assistance for clarification.
In the Guidance for the Content of Premarket Submissions for Software Contrained in Medical Device the FDA writes always about the Level of Concern for a software device (which i understand is the complete software)
In the 62304 the Classification for the Software can be done also be seperated for Components, Elements.
E.g I have a active component which I want to define as class A / minor level of concern and i have an independent safety component which completly controlls all hazards (Class C, major concern).
I can prove the independency of the two.
My question is can I split the Level of Concern on multiple software parts ?
Is there some more concret information from the FDA for this issue ?
If yes, what do i have to pay attention to ?
I am new to this forum and i really hope
to have some interesting discussions ...