Home > On-Demand Archives > Talks >
How to Win at 62304
Alan Cohen - Watch Now - Duration: 38:52
How to Win at 62304
Alan Cohen
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.
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!