Importance - Dinesh Puppala

Regulatory Affairs, SaMD & Digital Health Expert

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Safety First: Understanding the Importance of Recalls

on January 16, 2025January 16, 2025

TL;DR: Recalls are crucial for safety. Understanding why they happen and how to respond can protect you and your loved ones from potential harm. Keep reading to learn more about the importance of recalls and what you can do to stay safe. Hey there, friend! Let’s talk about a topic that might not be the …

The Importance of Compliance in FDA 510(k) Submissions for Medical Devices

on April 6, 2024April 6, 2024

The Importance of Compliance in FDA 510(k) Submissions for Medical Devices Every year, millions of medical devices are brought to market in the United States. These devices play a crucial role in the diagnosis, treatment, and management of health conditions, and are subject to rigorous regulatory oversight by the Food and Drug Administration (FDA). One …