Adopt
Sprint-based delivery with ceremonies (planning, review, retrospective). Retrospectives are not just a team health mechanism — they generate the continuous improvement evidence required by ISO 13485 §8.5.1 (CAPA input). Sprint planning records and velocity tracking constitute part of the IEC 62304 §5.1 software development plan.
Currently delivery is ad hoc. Formalising sprint structure is a Phase 1 priority — without it, the regulatory evidence trail has visible gaps. See Layer 05 (Delivery Process).