Medical-device change-control preparation draft. Not authorization to implement or market a device.

Device. DEVICE1

Change. CHANGE1. FICTIONAL bounded device change

Version transition. fictional-before to fictional-v1

Every exact design/manufacturing/labeling change. [{"reference":"ITEM1","sourceIds":["S1"],"area":"Design","beforeText":"FICTIONAL prior component","afterText":"FICTIONAL revised component","riskIds":["RISK1"],"testIds":["TEST1"],"approvedBy":"Fictional qualified reviewer","approvedOn":"2026-10-02"}]

Every risk assessment. [{"reference":"RISK1","sourceIds":["S1"],"changeItemReference":"ITEM1","hazard":"FICTIONAL selected hazard","beforeRisk":"FICTIONAL prior risk","afterRisk":"FICTIONAL current risk","control":"FICTIONAL qualified risk control","reviewer":"Fictional qualified reviewer","on":"2026-10-03","position":"Accepted"}]

Every verification result. [{"reference":"TEST1","sourceIds":["S1"],"changeItemReference":"ITEM1","deviceReference":"DEVICE1","deviceVersion":"fictional-v1","method":"FICTIONAL exact check","checkMode":"Literal equality","expected":"FICTIONAL preserved","actual":"FICTIONAL preserved","outcome":"Passed","testedOn":"2026-10-03","reviewer":"Fictional qualified reviewer"}]

Every current human decision. [{"reference":"DECISION1","sourceIds":["S1"],"kind":"Regulatory submission assessment","deviceVersion":"fictional-v1","position":"Approved","rationale":"FICTIONAL qualified determination. No automatic filing decision.","approvedBy":"Fictional qualified reviewer","approvedOn":"2026-10-04"},{"reference":"DECISION2","sourceIds":["S1"],"kind":"Implementation","deviceVersion":"fictional-v1","position":"Approved","rationale":"FICTIONAL human review assertion only","approvedBy":"Fictional qualified reviewer","approvedOn":"2026-10-04"}]

Missing supported decision kinds. 