In Memory of Yossi Elaz We are deeply saddened to share the news of Yossi Elaz’s passing. Yossi was a valued member of our BMTA team for 10 years. His creativity, problem-solving skills, and dedication were invaluable to our projects…
The FDA's Center for Devices and Radiological Health (CDRH) is committed to ensuring the safety and effectiveness of medical devices throughout their lifecycle. A crucial aspect of this oversight is postmarket surveillance, which involves monitoring devices after they enter the…
Advancements in digital health technologies, including artificial intelligence/machine learning-enabled medical devices (MLMD), necessitate developing regulatory expectations that are aligned with best practices for development and change management to support the quality of such devices. The change management process helps to…
