IMDRF
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
IMDRF
The new article describes the key terms and concepts used in adverse event reporting for medical devices.
CDRH
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
GMDN
This aticle highlights the importance of Medical Devices in the healthcare industry highlighting their key uses, developments and emerging technologies in the sector. Table of Contents Over the past few decades, there has been a significant evolution in medical...
FDA
The new article addresses the aspects related to modifications to existing medical devices already placed on the market and allowed for use in the US. The document describes in detail various types of changes and explains the way their regulatory status should be...
IMDRF
The new article describes in detail additional controls to be implemented with respect to medical devices that are no longer supported by their manufacturers. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary association of...
