[yshrestha]

We are 12 (and hiring). All engineers. Each of our client projects only need 2-3 engineers.

We specialize in software only medical devices. Engineers handle the design controls with input from product owners. We even got a product implemented and a 510(k) cleared using RDM and a team of just 3 engineers.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn...

It adds a little bit of overhead but we think it results in a better product in the end because engineers are thinking more about building the right thing as opposed to just building the thing right. It also results in a safer product since engineers are thinking about risk as they design and implement the product. Automated documentation generation also cuts down on manual process that required non-technical folks in the first place.