Predetermined change-control plans for AI/ML SaMD — how to make them audit-proof

I’ve spent the last three years defending algorithm updates to notified bodies and answering the same auditor question: “Show me how you control changes to this model.” For Class II software-as-a-medical-device (SaMD) where models will keep evolving, a predetermined change-control plan (PCCP) isn’t optional — it’s the practical way to show auditors you treated change control as governance, not theater. Below are the concrete patterns we used to build PCCPs and validation artifacts that survive I