Hello,
I have been looking into the level of concern for a piece of embedded software under development.
Question 4 of Table 1 of the FDA Premarket Submissions for Software guide, asks:
Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device?
As part of the design of the device a Preliminary Hazard Analysis was carried out which showed that a software failure might lead to a serious injury. As a result of the PHA the device is being designed so that there are hardware safe-guards to prevent any software failiures leading to serious injury.
My question is, does the "Prior to mitigation" part of Q4 mean that if the design is created (based on the PHA) that prevents software failures causing serious hazards, does this constitute a risk mitigation, and hence still qualify it as software of a major concern or can we say that the design is such that software failures cannot contribute to serious harm.
In effect, at what point in the design and development lifecycle should Q4 be asked?
Thanks
I have been looking into the level of concern for a piece of embedded software under development.
Question 4 of Table 1 of the FDA Premarket Submissions for Software guide, asks:
Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device?
As part of the design of the device a Preliminary Hazard Analysis was carried out which showed that a software failure might lead to a serious injury. As a result of the PHA the device is being designed so that there are hardware safe-guards to prevent any software failiures leading to serious injury.
My question is, does the "Prior to mitigation" part of Q4 mean that if the design is created (based on the PHA) that prevents software failures causing serious hazards, does this constitute a risk mitigation, and hence still qualify it as software of a major concern or can we say that the design is such that software failures cannot contribute to serious harm.
In effect, at what point in the design and development lifecycle should Q4 be asked?
Thanks