> 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.