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by jdgiese 1962 days ago
Thanks! We think so too. It's a daunting task to go from ISO13485 or IEC62304 to a set of process documents. We hope to continue improving RDM to lower the barrier for researchers and startup founders in the space. We're about to add templates for a low-overhead QMS within the next week or two.
1 comments

> It's a daunting task to go from ISO13485 or IEC62304

It can be a bit overwhelming, especially the first time, and especially from scratch.

I think for most people entering this space from a software point of view, the thing to get right first is some form of requirement management then later doc control. The QMS docs will come later too, but those two have the biggest impact on the engineering team itself.