Unit 13: Developer Guide to Conformity Documentation
Scenario: A medtech company launches an AI diagnostics tool.
What went wrong:
Dev team documented model performance, but not oversight plan
Compliance team assumed one existed
Post-launch audit flagged the gap — conformity file rejected
Fix:
Devs updated README and diagrammed where doctors reviewed decisions
Logs were added showing manual approvals and override triggers
Oversight plan was linked to deployment documentation
📌 Result: Passed audit on re-review — and avoided regulatory penalties.
