Risk Assessment Articles

Navigating the Evolving Landscape: Risk Analysis and Human Factors in AI-Enabled Medical Devices

by SoundRocket | Jun 24, 2025

The integration of Artificial Intelligence (AI) and Machine Learning (ML) into medical devices is revolutionizing healthcare, unlocking unprecedented opportunities in diagnostics, treatment, and patient care. Yet this swift technological advancement introduces complex...

FDA Risk Analysis for Your Medical Devices: What You Need to Know Now

by SoundRocket | May 17, 2025

FDA Risk Analysis, including Use-Related Risk Analysis (URRA), is no longer optional—it’s essential for medical device compliance. This guide explains URRA, why it’s vital for FDA submissions, and how to initiate effective risk management early in device development....

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FDA Risk Analysis for Your Medical Devices: What You Need to Know Now

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