Julio Zanon Diaz

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2papers

2 Papers

CVSep 6, 2025
Dual-Mode Deep Anomaly Detection for Medical Manufacturing: Structural Similarity and Feature Distance

Julio Zanon Diaz, Georgios Siogkas, Peter Corcoran

Automated visual inspection in medical-device manufacturing faces unique challenges, including extremely low defect rates, limited annotated data, hardware restrictions on production lines, and the need for validated, explainable artificial-intelligence systems. This paper presents two attention-guided autoencoder architectures that address these constraints through complementary anomaly-detection strategies. The first employs a multi-scale structural-similarity (4-MS-SSIM) index for inline inspection, enabling interpretable, real-time defect detection on constrained hardware. The second applies a Mahalanobis-distance analysis of randomly reduced latent features for efficient feature-space monitoring and lifecycle verification. Both approaches share a lightweight backbone optimised for high-resolution imagery for typical manufacturing conditions. Evaluations on the Surface Seal Image (SSI) dataset-representing sterile-barrier packaging inspection-demonstrate that the proposed methods outperform reference baselines, including MOCCA, CPCAE, and RAG-PaDiM, under realistic industrial constraints. Cross-domain validation on the MVTec-Zipper benchmark confirms comparable accuracy to state-of-the-art anomaly-detection methods. The dual-mode framework integrates inline anomaly detection and supervisory monitoring, advancing explainable AI architectures toward greater reliability, observability, and lifecycle monitoring in safety-critical manufacturing environments. To facilitate reproducibility, the source code developed for the experiments has been released in the project repository, while the datasets were obtained from publicly available sources.

CYAug 27, 2025
Navigating the EU AI Act: Foreseeable Challenges in Qualifying Deep Learning-Based Automated Inspections of Class III Medical Devices

Julio Zanon Diaz, Tommy Brennan, Peter Corcoran

As deep learning (DL) technologies advance, their application in automated visual inspection for Class III medical devices offers significant potential to enhance quality assurance and reduce human error. However, the adoption of such AI-based systems introduces new regulatory complexities-particularly under the EU Artificial Intelligence (AI) Act, which imposes high-risk system obligations that differ in scope and depth from established regulatory frameworks such as the Medical Device Regulation (MDR) and the U.S. FDA Quality System Regulation (QSR). This paper presents a high-level technical assessment of the foreseeable challenges that manufacturers are likely to encounter when qualifying DL-based automated inspections -- specifically static models -- within the existing medical device compliance landscape. It examines divergences in risk management principles, dataset governance, model validation, explainability requirements, and post-deployment monitoring obligations. The discussion also explores potential implementation strategies and highlights areas of uncertainty, including data retention burdens, global compliance implications, and the practical difficulties of achieving statistical significance in validation with limited defect data. Disclaimer: This paper presents a technical perspective and does not constitute legal or regulatory advice.