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Comment by jdgiese | Hacker News Reader

@ska, our development firm specializes in medical imaging software. A recent project involved a surgery navigation system. I know you are looking for on-site full time hires, but let me know if you would like to chat. My email is in my HN profile.

(BTW if you are shooting for IEC 62304 compliance, you may want to checkout https://github.com/innolitics/rdm ; it isn't as polished as we would like, but we have a lot of interest in this tool)

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Thanks for the link, I'll have a proper look later. I've done 62304 a few different ways in the past, one of the issues you run into is integration with your QMS and hardware ECR processes.

> I've done 62304 a few different ways in the past, one of the issues you run into is integration with your QMS and hardware ECR processes.

Absolutely; I think the regulatory documentation management needs for software and hardware are different. E.g., several of our clients (including one we used our RDM tool in conjunction with) use https://www.greenlight.guru. They seem to like it for hardware work, but we have had a tough time using it for software work.

One big problem we see with our RDM tool is that it isn't very usable for non-developers. Thus, it makes sense primarily for smaller early stage teams where they don't have and regulatory specialists.

That's a pretty small window, size wise - you don't have to be very big before it makes sense to bring someone in to focus on regulatory, especially if you are trying to move quickly to approval to market. W

I'll have a closer look though, for sure.

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