- How big is the company? - How did you get non-tech folks onboard with this approach?
- How big is the company? - How did you get non-tech folks onboard with this approach?
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.
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.