On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...
With the deadline for UDI compliance quickly approaching (Sept 2015 or Sept 2016 according to the FDA extension list), the FDA began accepting GUDID account requests from labelers of implantable, life-supporting, and life-sustaining medical devices on January 26,...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
