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That's true, those are merely popular examples of how engineering is done in med device, and not specific to the software side, though there are standards and guidance documents for specific fields. I didn't want to get too off in the weeds. But to be a 13485-compliant device developer, you need to have a competent requirements-driven, verified and validated development cycle, release process, and a complete design history with traceability all throughout, so you can immediately link problems to the actual components that caused them.

As an analogy, it takes the bill-of-materials approach done by popular package managers and makes it a whole lot more rigorous.



I do this, and it's a little onerous, but it's mostly just half-decent engineering. E.g. every commit has a ticket; every ticket has clear test criteria and a requirement to link back to (also a ticket, sometimes), every PR has a reviewer, every PR is tested by someone, every release knows what commits it has in it. Most of it can be done by Jira (or similar) and Git, and a fairly normal process. Not a Amazon-style 1000 changes a day sort of process, but still.


> But to be a 13485-compliant device developer, (...)

Those would be engineers, mainly mechanical engineers or electrical engineers.




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