Learn more about our Regulatory Affairs work.
Unequal access to medical technologies and, more broadly, health care services continues to persist – often disproportionately impacting the lives of racial and ethnic minorities.
This white paper discusses the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software.
Unequal access to medical technologies and, more broadly, health care services continues to persist – often disproportionately impacting the lives of racial and ethnic minorities.
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”.
Proper servicing of complex, life-saving medical devices is vital to their safe and effective functioning and the safety of patients and device users.
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…
WASHINGTON, DC. – A top FDA official warned that additional closures of ethylene oxide (EtO) sterilization plants could lead to shortages of critical medical devices across the country.