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February 16, 2026Open Access

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

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Pilot study demonstrates reproducibility in medical device workflows, suggesting reduced deficiencies and review times.

Evaluate a framework for structural risk identification in medical device regulatory submissions.
Pilot study across 400 anonymised medical device submissions
Integration of a pre-submission readiness system and Certificate Pre-Verification System (CPVS)
Comparison of system-generated deficiency flags with reviewer-identified deficiencies
System demonstrated 92.5% recall and 94.1% precision in identifying deficiencies
Manual review time reduced from 5-7 hours to under five minutes
Framework enhances auditability and reproducibility in submission processes

Kashif Saleem (2026) studied this question.

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