Hi Nash,
Looking at your original document with the definitions and risk matrix, I would suggest that it may help to add another level to your present 2 for acceptability.
So, at the moment you have a choice between acceptable and not acceptable. I would add an in-between level; something like "Undesirable - Risk is acceptable only if it cannot be reduced by controls which do not reduce the clinical usefulness of the device"
This level (amber?) could occupy the diagonal line of your matrix from P5/A1 to P1/A5.
Looking at your original document with the definitions and risk matrix, I would suggest that it may help to add another level to your present 2 for acceptability.
So, at the moment you have a choice between acceptable and not acceptable. I would add an in-between level; something like "Undesirable - Risk is acceptable only if it cannot be reduced by controls which do not reduce the clinical usefulness of the device"
This level (amber?) could occupy the diagonal line of your matrix from P5/A1 to P1/A5.
