IVDR Compliance for Large-Panel Next-Generation Sequencing (NGS) Devices: A Strategic Guide

Achieve IVDR compliance for large-panel Next-Generation Sequencing (NGS). Validate genetic variants and meet performance requirements with the right strategy.

Annelies Rotthier

June 25, 2025· Updated Mar 10, 20260 min read

Clinical EU IVDR

About the Author

Annelies Rotthier

15 years of experience in IVD field · Business Unit Manager IVD CRO

IVD Clinical Evidence and Medical Writing. IVD Product Development and IVDR Compliance. Strategic leadership & Consultancy.

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End-to-end clinical trial management from strategy to submission for medical devices, IVD, and pharmaceuticals.

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