Home > On-Demand Archives > Talks >
How to Win at 62304
Alan Cohen - Watch Now - Duration: 38:52
IEC 62304 is the worldwide standard for developing medical device software. In this presentation, we'll start with a brief overview of the standard, then we'll look at how we can use it, along with some recent FDA regulation changes, that can substantially reduce development efforts while also increasing device safety.
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!