Regulatory Drift Budget (RDB): A Quantitative, Auditable Risk‑Control Framework for Dynamic Change Management in SaMD, IVD, and Medical Devices.

We introduce the Regulatory Drift Budget (RDB), a quantitative and audit‑ready risk‑control framework that converts statistical drift monitoring into pre‑authorized regulatory action under a PCCP. RDB integrates a calibrated drift‑to‑risk map over time to form a cumulative budget with a pre‑alert (θ·B_reg) and a mandatory execution threshold (B_reg), followed by a reset. Under a minimal additive hazard linkage, capping the budget provides a non‑asymptotic bound on cumulative hazard and a simple operational lifetime estimate. Simulated SaMD/IVD/MD case studies show earlier and safer interventions than point thresholds or PSI‑like heuristics, stabilized IVD seasonality, and measurable RPN reductions in FMEA. The package includes implementation guidance, governance patterns (including group‑aware RDB‑G), and a regulator‑ready audit trail that ties PMS, ISO 14971, QMSR, IVDR PMPF, and PCCP execution together. Cite as (APA):Zadehnor, M. (2025). Regulatory Drift Budget (RDB): A Quantitative, Auditable Risk-Control Framework for Dynamic Change Management in SaMD, IVD, and Medical Devices. Zenodo. https://doi.org/**10.5281/zenodo.17518146 BibTeX: @misc{Zadehnor2025_RDB, title = {Regulatory Drift Budget (RDB): A Quantitative, Auditable Risk-Control Framework for Dynamic Change Management in SaMD, IVD, and Medical Devices}, author = {Mehdi Zadehnor}, year = {2025}, publisher = {Zenodo}, version = {1.0.0}, doi = {10.5281/zenodo.17518146}, note = {CC BY 4.0}}