Dynamic Failure-Probability Updating from Quality-System Signals: A Monotone Transfer Model for Risk and Reliability Monitoring
Year: 2025
Type: preprint
Abstract: This preprint (v1.3a) introduces QRTF, a QMS-integrated quantitative risk transfer framework for QA/QMS risk monitoring in regulated MedTech contexts. The approach combines structured QMS signals with a monotone logistic fusion model to generate an auditable, probability-like risk score intended for decision support (not a calibrated clinical probability). The manuscript focuses on the framework definition, data contract, and implementation-ready structure. FilesThe record contains the preprint PDF only. Supplementary packages may be released as a separate Zenodo version after journal submission.
Author: Zadehnour, Mehdi
Language: English
Subfield: Safety, Risk, Reliability and Quality
Field: Engineering
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7117708954