I3CGlobal FDA 510k, IVDR January 15, 2026

Anti-Mullerian Hormone Test System

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I3CGlobal IVDR, FDA 510k January 15, 2026

Adrenocorticotropic hormone (ACTH) test system

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I3CGlobal Uncategorized January 12, 2026

Personalised Medical Devices

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I3CGlobal IVDR January 2, 2026

Data Relevance of the EU Population

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I3CGlobal Medical Device January 2, 2026

Smart Implantable Medical Devices

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I3CGlobal IVDR, FDA 510k November 24, 2025

Syphilis Kit 510k and IVDR Process

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I3CGlobal IVDR November 9, 2025

Upgrading QMS to IVDR Requirements

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I3CGlobal FDA 510k, IVDR November 5, 2025

Qualitative HBV RT PCR Kit

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I3CGlobal MDQMS IQA June 27, 2025

ISO 13485 Clause 8.3.3 Advisory Notice For Medical Device

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