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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I3CGlobal FDA 510k June 25, 2025

General Reagents in IVD (In Vitro Diagnostics)

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I3CGlobal FDA 510k June 25, 2025

Unclassified Medical Devices from 510(k)

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I3CGlobal FDA 510k June 25, 2025

Humanitarian Device Exemption

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I3CGlobal FDA 510k June 25, 2025

User Fees and Refunds For 510k Submission

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I3CGlobal FDA 510k June 25, 2025

Freedom of Information Act (FOIA)

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I3CGlobal FDA 510k June 13, 2025

IVD Controls

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