#Matrix iso 14971 2012 free download software

Its not clear to me how you would apply your risk acceptability criteria to this example.Ĭlick to expand.For the first one, I would add that the main thing is - risk acceptability has to take into consideration more than just the components of the definition of risk (combination of probability and severity) and thus the risk acceptability criteria should not be only about probability and severity.įor the second one I would add that a risk matrix is always a risk ranking tool (it's the nature of the tool), so it should be used accordinglyįor the third one, I would add that you can use a risk matrix with regions, but if you do, you should again use it as a guide to ranking only, not to really accept risk.

#Matrix iso 14971 2012 free download software

Another example is as part of 63204 when determining software classification you need to consider whether failure of your software will lead to unacceptable risk. For example I'm sure 60601-1 has lots of clauses with wording to effect.

Note, I am aware that you need to justify the residual risk is acceptable so that kind of ensures you can't have unreasonable criteria.Īs a followup, I can't help but wonder if you use a risk acceptable criteria as you suggested in your first post, how do you apply this to other standards that require you to ensure the risk is acceptable. But if you do, there is no requirement to explain what rationale was used to set your areas of acceptable risk or unacceptable risk. Avoid using a risk matrix with regions labelled acceptable and unacceptable as part of your risk acceptability criteria. If you are using a risk matrix as part of you risk acceptability criteria you should be using it as a risk ranking tool. Ideally define risk acceptability criteria similar to the suggestion in your first reply. Should I limit the RAC criteria to be based on acceptable harm due to design/engineering faults given similar state of the art devices and then perform risk vs benefit analysis to justify risks that are inherit with the therapy or is there some other approach that is more suitable? So if I don’t use risk related to therapy to define my matrix, what process should I use to define the acceptable region. you should not be able to justify poor engineering just because there is some inherit risk associated with the therapy. The problem I see with this approach is that just because there are some inherit harms (with certain probabilities and severities occurring) you shouldn’t make these acceptable in your matrix as the matrix doesn’t explicitly cover the source of the harm i.e.

being exposed to x-rays as an unavoidable consequence) fall into the acceptable region? Clearly the benefits outweigh the risk but should I construct my RAC table so severities and probabilities that align with this use (i.e. For example, when using an x-ray there is some harm associated with the therapy. Conceptually, when defining a RAC matrix should the acceptable area cover known unavoidable risks associated with the therapy. Specifically about the use of a matrix as per Annex D. I have a question about defining Risk Acceptability Criteria (RAC) as required by 14971:2007.