Kwang-Man Ko, Department of Computer Engineering, Sangji University,83 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea
This study proposes a traceable method for converting multi-jurisdictional cybersecurity and software-quality requirements into two quantitative compliance indicators for digital medical devices and evaluates its methodological validity through simulation. Requirements from the Korean MFDS, the U.S.FDA, the EU MDR and MDCG guidance, IMDRF guidance, and relevant IEC, ISO, and AAMI standards are consolidated into traceable verification items. A compensatory Weighted-Sum indicator summarizes overall development progress, whereas a Jurisdiction-Bottleneck indicator identifies the lowest jurisdictionspecific level of compliance. A simulation-based evaluation using a ten-item insulin-pump scenario examines the calculation procedure and decision-making behavior of the proposed indicators. The simulation yields Weighted-Sum and Jurisdiction-Bottleneck scores of 69.0% and 60.0%, respectively. Sensitivity analysis using alternative enforceability encodings confirms the stability of the identified bottleneck, while counterfactual analysis distinguishes item-level improvement effects from denominator effects. These results demonstrate the computational consistency, interpretability, and complementary decision behavior of the proposed indicators. However, the simulation does not establish industrial effectiveness, inter-rater agreement, or the ability to predict actual regulatory approval outcomes.
Digital Medical Devices, Medical Software, Standard Compliance Evaluation, Quantitative Evaluation Index
