Access our full library of guidance, white papers, and other resources developed by and for the medical technology industry.
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.
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.
Brought to you by AdvaMed®, Medtech POV with Scott Whitaker is a podcast that covers the intersection of medtech and policy from every perspective.
This publication series explores “Software as a Medical Device (SaMD),” its challenges and the ways regulatory bodies try to address them, as well as the expected development of regulations related…
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…
This white paper discusses the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software.
This white paper explores how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”.