Thanks for the quick response Marcelo; much appreciated.
My biggest remaining concern in all of this is interpreting "foreseeable misuse", which can then lead to additional hazard/harm not considered when we did the safety classification of our device per IEC 62304, which we concluded was Class A. I really liked the example you provided about the red/green colours as a control method, which was used in a counter-intuitive method. However, what happens when you have a grey coloured button which could be interpreted in different ways?
To be specific, our SW device is an aid for people with visual impairment, intended to assist users with their typical "activities of daily living"; the fallback in any device failure is to just revert to their typical visual acuity (aided on non-aided...i.e. prescription eyewear). However, once you have this aid, some users may get a false sense of confidence and decide to go do things they typically wouldn't do with their typical visual acuity and who knows just what they might decide to do; it could be endless. There could potentially be some scenarios we could foresee, but people are people and who knows what they'll go out and do. We provide over 6 months of on-hand training to users when the product is delivered which includes cautioning them on proper use of the device, but I'm not sure anymore if such training would be considered an acceptable control method.
So i find I am spending more time trying to interpret the standard, while maybe I should just spend time interpreting the directive and find the best approach (although there would be similarities on how to go about it).
So that's where I am coming from. Our product is low risk, as long as people aren't stupid about it, to put it bluntly.
I carefully chose the title of this post when I started it, using the word "interpretation", because that's what i am struggling with, and concerned it may cause undue churn in our safety classification due to simply understand a standard. We did a good exercise when implementing 62304 and did identify potential safety concerns which were validated through hardware measures, and we are comfortable with the Class A classification. So I don't want to compromise that.
The feedback has been very helpful, though this "foreseeable" is still a bit mystic, given that we have a "grey" coloured control option to cnoisder (poor analogy maybe on my part...

).
Thanks again.