AI Code in Regulated Healthcare

A field report on maintaining regulatory traceability when AI writes code for software-as-a-medical-device systems.

• The regulatory frameworks healthcare engineers already live with — IEC 62304, FDA SaMD, MDR.
• How AI code generation breaks requirement-to-implementation traceability by default.
• How executable architecture produces the structured evidence regulation expects.

The implementation can be regenerated faster than the validation evidence can be produced. That asymmetry is the whole problem.

The full argument, evidence and recommendations continue in the report.