2025 - November ASQ Orange Empire, Section 0701, Monthly Meeting

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The purpose of Unique Device Identification (UDI) of medical devices is to improve patient safety. The original UDI guideline was published by the International Medical Device Regulators Forum (IMDRF) in 2013. The first UDI regulation was published by the US FDA. The UDI became a requirement of the EU with the publication of the EU MDR and IVDR. Other countries have followed suit including South Korea, Taiwan, Turkey, Japan, China, ASEAN, Kingdom of Saudi Arabia, Australia and Brazil. Other countries have announced plans to implement UDI but do not have firm dates or guidances. These systems are similar, generally following the IMDRF guideline.

UDI systems are comprised of two parts: labeling and a database. The system is only as good as the data in the database, the accuracy and quality of the labeling, and the completeness of traceability in the supply chain. To ensure a robust system, validation of data, database entries, label design, label printing in manufacturing is needed. Examples of validation strategies, templates, and equipment will be discussed.

Annemarie Belteu is owner of Belteu Engineering and Supply Chain AutoIdentification Solutions. She has 36 years progressive experience in R&D, Production, Distribution, IT, Quality and Regulatory for global medical device and IVD manufacturers. She is a Certified Project Management Professional and is certified by GS1 in Advanced Standards. She consults on Global UDI regulation implementation utilizing her experience and skills in process engineering, systems engineering, interdisciplinary team management and participation, virtual team management; technical writing, bar code label design, validation, quality function deployment and continuous process improvement. She has helped over a dozen medical device companies comply with Unique Device Identification world-wide.

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Across industries, postmarket surveillance is often viewed as a regulatory requirement rather than a strategic advantage. Yet, hidden within these data streams are powerful insights that can prevent future issues, enhance patient safety, strengthen design robustness, and accelerate innovation.

This session explores how organizations can evolve their postmarket surveillance systems from reactive reporting tools into proactive intelligence engines. Participants will learn practical approaches to extract meaningful trends, integrate cross-functional feedback loops, and use postmarket insights to drive business decisions. By transforming compliance activities into strategic learning systems, companies can strengthen customer and patient trust—ultimately preserving brand reputation and unlocking new opportunities for growth.

Jaime , as a global leader, has supported organizations achieve these goals by enhancing the operational effectiveness and fostering a collaborative environment where every team member is empowered to contribute to ensuring product safety and excellence.

· Optimization of Global Quality Functions – Transformed quality systems into proactive, risk-based frameworks, strengthening compliance sustainability and patient safety.

· QMS simplification – Achieved significant cost savings by streamlining QMS certificates and Notified Bodies across multinational organizations.

· Regulatory & Compliance Leadership – Led organizations through FDA warning letter resolutions and major compliance challenges, optimizing QMS structures and fostering global collaboration.

· Post market Surveillance Optimization– Transformed complaints handling, corrections & removals, sustaining engineering, and risk management organizations by streamlining processes, enhancing efficiency, and elevating team competency.

· Enterprise System Implementation – Successfully led the deployment of enterprise complaint and CAPA systems, integrating cross functional processes and organizations while avoiding costly delays.

Corrections & Removals Optimization – Improved escalation, reporting, and execution of corrective actions and accelerated time-to-market by reducing waste and by optimizing global operational efficiency across cross functional groups.

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Host or Publisher ASQ Orange Empire Section 0701