Medical device developers face a tough challenge: embedding IEC 62304 into modern DevOps without sacrificing speed. The standard demands proof that risk controls work and changes are managed. This means creating an evidence pipeline that connects hazards to releases. Forget heavy documentation; the goal is operationalizing compliance through pull requests, CI/CD, and automated testing.

Start by defining your software safety class—A, B, or C. This choice dictates the rigor for verification and traceability. The smartest teams treat compliance as a graph problem, not a document dump. A minimum viable graph links hazards to risk controls, requirements, design, code, tests, and results. This mapping is essential for surviving audits without last-minute heroics.

A practical repo structure aligns files to the lifecycle: planning, risk, requirements, design, and release folders. Engineering teams can enforce traceability using typed IDs like SRS-### and RC-###. Pull request templates should mandate these links. CI builds then generate trace reports, failing the build if connections are missing. This turns traceability into an enforceable contract.

Managing SOUP (Software of Unknown Provenance) requires a dependency inventory and pinned versions. Verification needs tiered testing—unit, integration, and system—with CI exporting audit-friendly artifacts. Change control is simply a structured Git workflow. Ultimately, this approach prevents the biggest audit failure: documentation diverging from reality by generating evidence directly from the pipeline.