IEC 62304 is the software lifecycle standard for medical device software, and most engineering teams meet it the same way: a compliance consultant hands over templates, the team fills them in retroactively before an audit, and everyone agrees never to speak of it again. That approach technically produces documents. It doesn’t produce a process — and it definitely doesn’t survive the second release.
Read as an engineer rather than an auditor, the standard asks for a handful of things, most of which strong teams already half-do:
The core asks, translated
Know your safety class. The standard scales its demands by harm potential (Class A/B/C). Getting this classification right — usually with your RA/QA team, and per software item, not per product — determines how much of everything else applies. Over-classifying is as costly as under-classifying.
Requirements you can point to. Not a 400-page document — a numbered, versioned set of statements about what the software must do, each traceable forward to the code and tests that implement it. If you use an issue tracker with discipline, you are closer than you think.
Traceability as a byproduct. The audit question is “show me the tests for this requirement.” If your commits reference issues and your CI publishes test results, that answer can be a query instead of a spreadsheet-weekend. Tooling, not heroics.
Risk-driven verification. Test depth follows harm, and known anomalies are recorded and dispositioned, not silently tolerated. Every team has a bug backlog; the standard just asks you to be honest about what’s in it when you release.
A real change process. What changed, why, what it affects, who approved it. A disciplined pull-request workflow with review is 80% of this — the remaining 20% is impact analysis and keeping the record.
SOUP under control. Your dependencies (Software of Unknown Provenance) need an inventory with versions and known issues — which modern SBOM tooling generates in CI for free.
The pattern that works
Wire the evidence into the tools engineers already use, so the audit trail accumulates as a side effect of normal work. Teams that do this ship faster after adoption, because the same traceability that satisfies an auditor also answers “what breaks if we change this?” That’s the entire premise of our Compliance-Ready SDLC package — and the reason its final phase is shipping a real feature through the process, not delivering a binder.
One caveat that belongs in every article like this: aligning your process with IEC 62304 supports your regulatory strategy; it doesn’t constitute clearance or certification. That judgment belongs to your regulators and notified bodies.