Preharm Signal Convergence Framework for Postmarket Surveillance of Medical Devices and IVDs

This preprint presents the Preharm Signal Convergence Framework (PSCF), a theory-backed, method-oriented framework for earlier and more structured postmarket signal escalation in medical devices and in vitro diagnostics (IVDs). The framework does not propose a universal law of postmarket surveillance. Instead, it formalizes how weak but concordant signals from multiple heterogeneous sources may become operationally actionable when they remain product-anchored, persist after artifact and confounding controls, and exceed predefined escalation conditions. PSCF introduces a decision-linked structure centered on identity certainty, multisource convergence, confounder penalties, lead-time gain, and explicit falsification logic. The paper outlines the conceptual basis, boundary conditions, validation ladder, and empirical testing strategy for assessing whether structured convergence can improve early knowability of clinically meaningful product risk relative to conventional surveillance approaches.