This Zenodo record contains Version 1 of the preprint “Regulatory-Object-Centric Technical Documentation for Medical Devices: A Framework and Public-Data Empirical Stress Validation.” The article proposes RO-TD, a regulatory-object-centric framework for structuring medical-device technical documentation around the regulated object rather than the dossier file. The framework links object identity, boundary and variant logic, evidence applicability, labeling and IFU coherence, UDI and registration structure, post-market surveillance and vigilance traceability, change-control propagation, and market-route mapping. The central contribution is a regulatory-science architecture for reducing ambiguity in technical documentation by making explicit which evidence applies to which product, variant, accessory, kit, software version, label, UDI-linked record, post-market signal, and change-control pathway. The work is positioned as a framework with public-data empirical stress validation, not as a causal proof that the framework prevents recalls or adverse events. The empirical stress-validation layer uses official public FDA recall and correction records to assess whether the failure modes targeted by RO-TD recur in real-world medical-device safety records. The analysis supports the relevance of the framework across object-boundary definition, evidence/performance linkage, labeling and IFU coherence, UDI/identity traceability, PMS/vigilance attribution, and change-control/correction logic. This preprint is intended for regulatory science, medical-device quality management, technical documentation strategy, design-control governance, post-market surveillance, UDI implementation, and lifecycle evidence architecture.
Mehdi Zadehnour (Sun,) studied this question.