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Interesting. I do agree 62304 seems to mostly codify what we would consider best software principles anyway. Your statement about 14971 being the big shift in
by yshrestha 6y ago
Interesting. I do agree 62304 seems to mostly codify what we would consider best software principles anyway.
Your statement about 14971 being the big shift in thinking is interesting. With a bit of clinical context, do you think developers can write code with risk management in mind?
- ska 6y ago> With a bit of clinical context, do you think developers can write code with risk management in mind? Absolutely. Some people with more of a hardware bent are probably used to FMEA - but that requires a design to evaluate. Risk management approach (should) starts at the other end, while you are still understanding what your product should do. If you do 14971 right (and iteratively), it will help you pin down key requirements up front that will help you avoid missteps that are costly to recover later. One of the big shifts is that it makes you think about uncommon/incorrect usages earlier, as well as thinking about how other systems could mess with you.
- yshrestha 6y agoI agree risk management should start at the patient and work backwards to the individual units that themselves can be inputs into an FMEA. When the design gets a bit further along, you can perform an FMEA and repeat the process several times over the course of the design. I am always surprised at how many more risks can be identified by doing the process iteratively and frequently. Do you recommend any tools that have helped you perform risk analysis?