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

Published: June 17, 2026

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Cardiovascular Medical Device Trials in a Transformational Era

Published: June 10, 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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Pulsed Field Ablation FDA Approval: A Regulatory and Preclinical Roadmap

Published: May 20, 2026

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FDA TAP Program: A Practical Guide for Medical Device Manufacturers

Published: May 6, 2026

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The Regulatory Framework for Human Factors and Usability Engineering in Medical Devices

Published: April 29, 2026

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FDA QMSR: What Medical Device Manufacturers Need to Know

Published: April 15, 2026

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Sign reading "FDA, U.S. Department of Health and Human Services" in front of a modern brick building representing NAMSA's FDA consulting services

Navigating the FDA’s Total Product Life Cycle Advisory (TAP) Program

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Lessons Learned by Neurotech KOLs: Dr. Brian Litt and Dr. James Kryzanski

Published: April 1, 2026

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What Does FDA Breakthrough Device Designation Mean?

Published: March 18, 2026

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EDC Clinical Trials: Is Your EDC System Fit for Purpose?

Published: March 4, 2026

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The TEMPO Pilot Program: Key Strategic Guidance for Digital Health Manufacturers

Published: February 18, 2026

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NeuroTech Device Development: KOL Insights for Innovators

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From Study Design to Adjudication and Beyond: Building Robust Safety Strategies for Neurological Medical Devices

Published: February 11, 2026

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Understanding FDA Preclinical Animal Study Requirements for Medical Devices

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Why are Imaging Core Labs Essential for Medical Device Trials?

Published: January 14, 2026

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