Choosing a Regulatory Pathway for Software-Driven Devices

Regulatory strategy is frequently treated as a downstream activity. For software-driven devices it is an architectural decision.\n\nA predetermined change control plan, for instance, only helps if your model versioning, monitoring, and rollback are already built to support it. Retrofitting that after submission is significantly more expensive than designing for it.\n\nPractical guidance we give programs at kickoff:\n\n- Write the intended-use statement before writing production code. It constrains everything downstream.\n- Identify your predicate or comparator early; it defines your evidence bar.\n- Decide whether the model is locked or adaptive, and build the change-control machinery that choice implies.\n- Treat post-market surveillance as a product feature with an owner, not a compliance obligation.\n\nTeams that do this ship later on paper and reach patients sooner in practice.