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The Last Mile challenge in UDI when using ERP/PLM/QMS systems

In the medical device lifecycle, there is a paradox. We use sophisticated software to design products, advanced robo…
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UDI beyond US & EU: Navigating UDI Mandates in LATAM and APAC

For the last five years, the medical device industry has suffered from “tunnel vision,” fixated almost entirely on t…
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Electronic Instructions for Use (eIFU): The Complete 2026 Guide for Medical Device Manufacturers

The medical device industry is undergoing a major shift in how product information is delivered, driven by the rise …
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Unique Device Identification: The Complete Guide to Compliance, Benefits, and Future Trends

In the rapidly evolving world of medical technology, ensuring patient safety and traceability is no longer optional …
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AI Agents for Regulatory: Which Type is Right for You?

Discover different AI agent types with examples and which one suits your business needs. Learn about autonomous agen…
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