Deterministic Regulatory Engineering for Pre-Submission Structural Risk Identification in Medical Device Workflows: A Multi-Case Operational Pilot Study

Preventable structural deficiencies in medical device regulatory submissions contribute to prolonged review cycles, avoidable administrative burden, and increased compliance costs. This pilot study evaluates a deterministic regulatory engineering framework integrating a rule-governed pre-submission readiness system and a structured Certificate Pre-Verification System (CPVS). Across 400 anonymised medical device submissions processed within a regulated commercial submission facilitation environment aligned with publicly available national regulatory guidelines, system-generated structural deficiency flags demonstrated 92.5% recall and 94.1% precision relative to subsequent reviewer-identified structural deficiencies. Manual structural readiness review time, typically requiring 5–7 hours per submission, was reduced to under five minutes through deterministic rule execution with retained human oversight. The framework formalizes regulatory logic into structured applicability matrices, evidence grading schemas, and deterministic escalation pathways. Results suggest that regulatory engineering models may meaningfully reduce preventable administrative deficiencies while enhancing auditability and reproducibility in regulated submission ecosystems.