A
ariannas
I need to take the lead in defining risk acceptability criteria for a new small business that is developing a Class I software-only medical device. They have a lot of expertise in their area but are not clinicians and they know even less about formal risk management than I do. :mg:
I?ve been studying ISO/TR 80002-1 in detail, I?ve worked through the GHTF?s SG3/N15R8, and I?ve been digging through Elsmar as well. (Certain people have been getting a flurry of ?thanks-es? on existing posts lately) So now I have at least a little understanding of the theory, but when it comes to putting this stuff into practice, this is my first go at it.
Given that back story, here is my question:
Some caveats:
Based on what I have learned so far, I am going to have to go with a qualitative rather than quantitative approach. So if 14971?s guidance for establishing risk acceptance criteria is more focused on quantitative side of things, I?m not as interested in buying the standard.
In the short term, my goal is to come up with an approach that is practical for a small company and acceptable to the FDA. Full ISO is a dream for another day.
Thanks in advance!!!
I?ve been studying ISO/TR 80002-1 in detail, I?ve worked through the GHTF?s SG3/N15R8, and I?ve been digging through Elsmar as well. (Certain people have been getting a flurry of ?thanks-es? on existing posts lately) So now I have at least a little understanding of the theory, but when it comes to putting this stuff into practice, this is my first go at it.
Given that back story, here is my question:
How much real-world guidance does ISO 14971 provide for establishing risk acceptability criteria beyond what is already in ISO/TR 80002)?
If all that ISO 14971 says is that a) establishing risk acceptance criteria is critical, b) every manufacturer has to do it differently, and c) that it should be ?state-of the-art?, I don?t think I will want to spend the $300. But if it can give me some tools to achieve the goals above, I?m interested and willing to pony up.
Some caveats:
Based on what I have learned so far, I am going to have to go with a qualitative rather than quantitative approach. So if 14971?s guidance for establishing risk acceptance criteria is more focused on quantitative side of things, I?m not as interested in buying the standard.
In the short term, my goal is to come up with an approach that is practical for a small company and acceptable to the FDA. Full ISO is a dream for another day.
Thanks in advance!!!