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> Medicine has incredibly rigorous engineering processes (...) You're confusing with mechanical engineering applied to medical devices with medicine. It's lik

by rewmie 3y ago

> Medicine has incredibly rigorous engineering processes (...) You're confusing with mechanical engineering applied to medical devices with medicine. It's like claiming bakeries have incredible rigorous engineering processes just because mechanical and industrial engineers design devices and automate processes. Not the same thing, is it? > See: ISO13485, IEC60601, QMS, etc You're just pointing to standards that engineers working on specialized devices need to comply. One covers quality assurance and the other is focused on specialized electrical equipment.

ijustlovemath 3y ago
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.
- robertlagrant 3y ago
  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.
- rewmie 3y ago
  > But to be a 13485-compliant device developer, (...) Those would be engineers, mainly mechanical engineers or electrical engineers.

by rewmie 3y ago

ijustlovemath 3y ago

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.

robertlagrant 3y ago
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.
rewmie 3y ago
> But to be a 13485-compliant device developer, (...) Those would be engineers, mainly mechanical engineers or electrical engineers.