Two authored steps: a plain scope screen for whether your software is SaMD at all, then its IMDRF risk category (I–IV) read off the N12 matrix from the state of the healthcare situation and the significance of the information it provides. Free. Nothing you select leaves your browser.
Three scope gates, applied in order. This screen decides whether the risk matrix even applies to your product.
The scope screen, the category, the definitions, the examples and the matrix are free and stay free. The Regulatory Focus Edition adds what the category alone doesn't tell you: the evidence and lifecycle considerations that scale with each category, and the misclassification traps that quietly move a product a whole category.
Regulatory or RA/QA team licence? Email for a group rate.
Unlocks the Regulatory Focus Edition on this device and survives reloads. No account, nothing transmitted.