Unique Device Identification System (UDI) | i3c Global Solutions

An overview of the Unique Device Identification (UDI) System, highlighting its role in improving medical device traceability, regulatory compliance, and patient safety. This visual illustrates how UDI connects manufacturers, healthcare providers, and regulators through a standardized identification framework that simplifies tracking from production to use.

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IVDR Class C Certification & Compliance Services

Our IVDR Class C services help manufacturers of high-risk in-vitro diagnostic devices navigate the complex EU regulations with confidence. From conformity assessment and CE marking support to detailed risk management file preparation, we provide end-to-end solutions to ensure your products comply with IVDR standards. Partner with us to simplify your regulatory journey and bring your medical devices to market safely and efficiently.

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Performance Evaluation Report for IVDR | i3c Global

Get a comprehensive IVDR Performance Evaluation Report tailored to regulatory requirements. Learn how i3c Global ensures reliable clinical evidence and compliance success.


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