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Impact on MDR & IVDR Technical Documentation: Targeted Simplification Under COM(2025) 1023

Published: June 17, 2026

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Navigating MDCG 2025‑9: A Practical Guide for Manufacturers Developing Breakthrough Devices

Published: May 27, 2026

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How the CER Connects with PSUR, PMCF, and SSCP

Published: January 7, 2026

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MDR: Aspirations vs. Reality in Notified Body Practice

Published: December 17, 2025

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Transform Your IVD Evaluation: Key Learnings from 4 Years of Expert Panel Views

Published: August 12, 2025

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Risk Management for MDR: Extending Beyond ISO 14971:2019

Published: July 15, 2025

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Guide to Clinical Evaluation Reports (CER) for Medical Devices

Published: April 17, 2025

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The Newly Applied European Health Technology Assessment (HTA) Regulation: Implications for Medical Devices

Published: April 9, 2025

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Navigating the Regulatory Journey of Combination Products: A Focus on Material Characterization

Published: March 28, 2025

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Doctor touching digital healthcare icons; medical theme.

Guide to Post-Market Clinical Follow-up Requirements Under EU MDR (2017/745)

Published: March 18, 2025

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Two white medical tapes stacked beside shiny metal scissors on a dark surface.

Impact of PFAS Regulations on Medical Devices

Published: March 11, 2025

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Person in blue uniform writing notes on a clipboard in a medical setting.

Periodic Summary Update Report (PSUR) & Post-Market Surveillance Report (PMSR) for MDR Compliance

Published: January 22, 2025

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Smartphone displaying data next to a digital scale with a turquoise screen representing a NAMSA blog post about the EU MDR and IVDR's classification of medical devices

EU MDR and IVDR: Classifying Medical Device Software (MDSW)

Published: September 25, 2024

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People analyzing data on a computer screen, overlaid with digital graphics and charts representing a NAMSA blog post on FDA regulations of AI, Machine Learning, and SaMD

FDA’s Regulation of AI/ML SaMD

Published: September 25, 2024

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Published: August 13, 2024

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Summary of Safety and Clinical Performance Best Practices

Published: July 24, 2024

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