STED - Summary Technical Document Preparation
A Summary TEchnical Document (STED) is a standardized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF). The long term goal of STED is to standardize regulatory submissions for many countries. Currently, there are five participants actively using or evaluating STED as a pilot program: Australia, European Union, Japan, Canada (Class III and Class IV devices) and the United States. Canada will start requiring the STED format for most Class III and IV medical device license submissions by July 2010.
The information required for the preparation of a Summary Technical Document (STED) is similar to the documentation required for a US FDA 510(k) submission, European Technical File, and Japanese PMDA/RCB submissions.
Emergo Group has expertise in preparing submissions in the STED format and we can fully assist in preparing or reviewing submissions for your medical devices for any of the markets mentioned above.
