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.
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.
Currently we are with between 50 and 100 in total, the team in this example is with 9.
We are building inherently complex systems with high compliance and security impact. So all colleagues are aware that we need to manage a lot of requirements and design knowledge in the progress. So there is a strong motivation to re-use information, reducing work and room for errors. And it helps to have some people passionate about knowledge management and making Git-based workflows easy to use. For example by linking the Mkdocs-generated pages to the GitHub file editor.
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.