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MDRG 15/04/2024 MDRG 15/04/2024

Medical Device Lifetime Overview

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MDRG 12/04/2024 MDRG 12/04/2024

IVDR Implementation Plan Summary

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MDRG 10/04/2024 MDRG 10/04/2024

Navigating Language Requirements for Medical Device Manufacturers

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MDRG 08/04/2024 MDRG 08/04/2024

Enhanced Vigilance Reporting Guidelines for Breast Implants: MDCG 2024-1-4 Overview

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MDRG 05/04/2024 MDRG 05/04/2024

Guidance for Reporting Incidents with Cardiac Implantable Electronic Devices (CIEDs)

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MDRG 03/04/2024 MDRG 03/04/2024

Guidance for Vigilance Reporting on Coronary Stents and Delivery Systems

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MDRG 01/04/2024 MDRG 01/04/2024

Guidance on Vigilance for Cardiac Ablation Devices: Key Insights

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MDRG 29/03/2024 MDRG 29/03/2024

Guidance on Vigilance Reporting for CE-Marked Devices: An Overview

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MDRG 27/03/2024 MDRG 27/03/2024

EUDAMED Update v2.14.0 Highlights

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MDRG 25/03/2024 MDRG 25/03/2024

Clarifying "Significant Change" in Medical Devices: Health Canada's Updated Guidance

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MDRG 22/03/2024 MDRG 22/03/2024

Streamlining European Medical Device Nomenclature: MDCG 2024-2

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MDRG 20/03/2024 MDRG 20/03/2024

MDCG 2024-3: A New Benchmark for Clinical Investigation Plans

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MDRG 19/03/2024 MDRG 19/03/2024

Insights from the 6th Notified Bodies Survey on MDR/IVDR Certifications and Applications

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MDRG 18/03/2024 MDRG 18/03/2024

EU Artificial Intelligence Act Adopted

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MDRG 04/12/2023 MDRG 04/12/2023

MDSAP Quality Management System Manual Updated (6th Edition)

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MDRG 01/12/2023 MDRG 01/12/2023

New IVDR Notified Body – Sertio Oy

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MDRG 30/11/2023 MDRG 30/11/2023

Congratulations to Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi on their recent notification as a Notified Body under the MDR!

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MDRG 29/11/2023 MDRG 29/11/2023

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MDRG 27/11/2023 MDRG 27/11/2023

New MDCG 2023-4: MDSW

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MDRG 25/11/2023 MDRG 25/11/2023

Black Friday Sale Now On!

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