Claim Governance for Marketing & Promotional Materials in Medical Devices, IVDs, and SaMD

This Zenodo record contains the preprint “Claim Governance for Marketing & Promotional Materials in Medical Devices, IVDs, and SaMD.” The paper introduces an evidence-anchored and audit-defensible governance framework for external claims in regulated health-technology markets. Rather than treating marketing content as “soft” collateral, the framework treats each claim as a regulated semantic object that must be assessed for permissibility, evidence anchoring, and exposure risk across channels such as websites, brochures, congress materials, distributor content, and derivative translations. The framework provides a unified tier language (Low / Medium / High / Critical), explicit decision outcomes (GO-with-controls / STOP / NO-GO / DEFER), minimum evidence packages by claim class, and an operational control system built around auditable artifacts such as a claim-to-evidence matrix, claim envelope, web snapshot logging, distributor no-edit packs, and CAPA patterns for claim escapes. It also defines measurable KPI structures, an activity-level RACI model, and scenario-based validation logic across MD, IVD, and SaMD contexts. The contribution is methodological and operational rather than jurisdiction-specific legal advice. Its purpose is to provide a practical governance system that reduces claim escapes, intended-purpose drift, distributor propagation risk, and rework, while improving audit readiness and preserving marketing agility in regulated environments. Files in this record:1. Main preprint PDF. Note: implementation materials such as templates, logs, checklists, and operational forms are maintained as controlled artifacts and are available separately on request.