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Regulatory Affairs

Principles for Artificial Intelligence in Medical Technology

This document provides the medical device industry’s foundational principles for artificial intelligence in medical technology. These principles will guide further innovations, policymaking, and regulations in AI-enabled medical technology.

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Ethylene Oxide / Government & Legislative Affairs / Regulatory Affairs

Fact Sheet: EtO Sterilization Prevents Infection

Each year in the U.S., ethylene oxide sterilizes 20 billion medical devices, which are critical to preventing serious, even life-threatening, infections.

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Digital Health / Global & Trade / Legal / Regulatory Affairs / Small Business

Trendspotting 2022: On the Pulse of Life Sciences

Sidley’s Global Life Sciences group looks at 12 forces driving the life sciences legal and regulatory landscape in 2022, and provides practical tips on a range of topics for life…

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Regulatory Affairs

Industry 4.0 and Medical Devices

This white paper discusses the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software.

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