Adopt
Every sprint item must satisfy a Definition of Done that includes regulatory checklist items: risk class set, traceability link present (issue → PR → test case in TestRail), and tests passing. This connects the delivery process directly to IEC 62304 §5.1 compliance evidence — the sprint cadence, DoD criteria, and retrospective records collectively constitute the software development plan in action.
Without a DoD that includes these checkpoints, regulatory-grade traceability cannot be maintained at the speed of a sprint-based team. See Layer 05 (Delivery Process).