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Live Q&A - How to Win at 62304
Alan Cohen - Watch Now - Duration: 25:05
Hi Carl,
Thanks for your observations, they're quite reasonable. I think I mentioned in the presentation that the things presented are simplified to make a point, there's always lots more bits to consider. In practice, as it sounds like you know, any of these decisions end up requiring a good bit of thought!
On the second point, it's also possible that adding the summary screen could potentially reduce human factors risk.
Thank you, Alan, for a very informative presentation. I particularly like your design for regulatory (D4R) approach, which I would translate as "design for risk". This is a paradigm shift, where risk reduction becomes the top priority, which is not how developers usually think.
Of course, your tip to acquire the standards from Evs.ee is a very nice touch. I checked it out, and it works. They have much more than IEC-62304!
Thank you for your kind words, I'm glad it was helpful.
evs.ee is an amazing find. When I first found it, I couldn't believe it was real!
Thanks Alan. I thought this was a really good intro to 62304 and I was impressed with what you covered in the time. I found your example of the input screens ("reducing footprint") interesting and thought it was a shame you didn't have time to dig into it a bit further. While the addition of a dose summary screen seems a good risk control measure, there are two aspects of this example that prove challenging in practice if attempting to claim a reduction in safety class:
I'm always interested to hear how other engineers handle such cases. Thanks!