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Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Per- and polyfluoroalkyl substances, known as PFAS, are a broad class of over 12,000 substances that are found in a variety of consumer, commercial and industrial products, including medical devices…
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Outlining the facts and dispelling myths will inform policymaking to avoid overlap with current regulations and preserve the broad capacity of innovation to help patients.
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.
Brought to you by AdvaMed, Medtech POV with Scott Whitaker is a podcast that covers the intersection of medtech and policy from every perspective.
Medical device manufacturers take seriously the need to continuously assess the security of their devices.
Sunrise Labs outlines a systems approach to medical device requirements for efficient design and development..
This AdvaMed position statement is intended to provide clarity about the transition away from the acronyms NDC/NHRIC to NRC, including rationale and implications.
Each year in the U.S., ethylene oxide sterilizes 20 billion medical devices, which are critical to preventing serious, even life-threatening, infections.