Pre-Market
Every year, the FDA reviews thousands of devices to assure that they are safe, effective, and high-quality.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Technology & Regulatory Affairs
AdvaMed advocates and works for a consistent, predictable, and transparent regulatory system.
Seniors Should Have Access to Breakthrough Medical Devices. Here’s Why
Unequal access to medical technologies and, more broadly, health care services continues to persist – often disproportionately impacting the lives of racial and ethnic minorities.
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.
CMS Policy Update Breathes New Life into Care Options for Medicare Beneficiaries
Unequal access to medical technologies and, more broadly, health care services continues to persist – often disproportionately impacting the lives of racial and ethnic minorities.
Optimizing CAPAs in the Medical Device Industry
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”.
Third-Party Servicing of Medical Devices
Proper servicing of complex, life-saving medical devices is vital to their safe and effective functioning and the safety of patients and device users.
The Virtual Medtech Conference Opens with On-Demand Offerings
WASHINGTON, D.C. – The Virtual Medtech Conference, powered by AdvaMed, kicks off its first week of on-demand content with a slate of informative sessions providing something for everyone in the…