AI in medical devices industry Archives

FDA Regulations for AI in Medical Devices: Comprehensive Guide

by Sudhriti M | Sep 10, 2026 | Medical Device

The FDA currently regulates AI in medical devices through existing pathways (510(k), De Novo, PMA). However, it has issued draft guidance and new discussion papers to address AI-specific risks, namely bias, transparency, and continuous learning. In this blog, we have...

EU AI Act for Medical Devices: 5 Key Obligations

by Sudhriti M | Aug 3, 2026 | Medical Device

The EU AI Act introduces a new compliance layer for AI-enabled medical devices in Europe. It requires manufacturers to meet both EU MDR/IVDR and AI Act obligations. High-risk AI medical devices must now address AI-specific requirements, such as data governance, risk...

Using Artificial Intelligence in Medical Devices Industry

by Sudhriti M | Sep 19, 2024 | Medical Device

Artificial intelligence is a powerful and disruptive domain in the field of computer science. It empowers machines with the ability to perform tasks that usually require human intelligence. Furthermore, artificial intelligence (AI) enabled-machines match or improve...

FDA Regulations for AI in Medical Devices: Comprehensive Guide

EU AI Act for Medical Devices: 5 Key Obligations

Using Artificial Intelligence in Medical Devices Industry

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