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Hi! I'm a first time "poster" and I'd like to first of all thank everyone in this forum - there is some really great stuff posted here!
I've just been hired into a software development company that develops common filter and image enhancement software libraries for use in a variety of medical imaging equipment.
We want this software to be IEC62304 compliant to reduce any obstacles our clients may have in wanting to adopt our technology.
But when I read IEC62304, I'm confused because it seems to apply to software that is being developed as part of a development program for a single medical device.
And since out software is intended for medical devices, it doesn't fit the definition of SOUP.
Does IEC62304 apply to this kind of software?
I've just been hired into a software development company that develops common filter and image enhancement software libraries for use in a variety of medical imaging equipment.
We want this software to be IEC62304 compliant to reduce any obstacles our clients may have in wanting to adopt our technology.
But when I read IEC62304, I'm confused because it seems to apply to software that is being developed as part of a development program for a single medical device.
And since out software is intended for medical devices, it doesn't fit the definition of SOUP.
Does IEC62304 apply to this kind of software?