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This work aims to redefine how medical-device design control maturity is assessed, focusing on evidence continuity rather than documentation volume.

April 26, 2026Open Access

Evidence Continuity, Not Documentation Volume: A Lifecycle Design-Control Architecture and Maturity Index for Medical Device Development under FDA QMSR and ISO 13485

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Randomized trial evaluates design control evidence continuity in medical devices, suggesting improved regulatory compliance.

This work aims to redefine how medical-device design control maturity is assessed, focusing on evidence continuity rather than documentation volume.
Introduced the Design-Control Evidence Continuity Model (DCECM) linking various design-control elements.
Defined a discontinuity taxonomy to identify failures in design-control evidence chains.
Proposed the Design-Control Evidence Continuity Index (DCECI) for maturity assessment based on design-history-file reviews and audits.
Identified key weaknesses in design-control processes using public FDA inspection data.
Highlighted the importance of continuity in objective evidence throughout the product lifecycle.
Established a structured approach for evaluating design control maturity, yet DCECI requires validation.

Mehdi Zadehnour (2026) studied this question.

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