Tag: IVDR 2017/746

ISO 17511: Metrological Traceability for IVD Medical Devices

Medical Devices December 1, 2022

A new version of ISO 17511 has been recently published and in this article we will dig into the requirements of this ISO standard,...

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Systems and Procedure Packs according to Article 22 of EU MDR

Medical Devices November 26, 2022

Article 110 of EU IVDR 2017/746 : An Overview

Medical Devices June 18, 2022

Performance Evaluation Plan according to IVDR 2017/746

Medical Devices April 26, 2022

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