What Software Teams Can Learn from ISO 13485, the Medical Device Quality System

Software bugs can be patched after release, but a defective medical device can cause real injury, which is why device makers rely on ISO 13485. The author argues that this quality management standard, which may look like bureaucracy, contains engineering practices that software teams often adopt only after a major outage. Key parallels include design controls that trace requirements through a signed, versioned development history, and CAPA processes that close the loop on incidents. The article also highlights risk management under ISO 14971, where hazards are scored and mitigated with traceable, signed-off actions, and process validation, which treats a reliably repeatable process as the basis for quality rather than inspection alone.