Finding the right information for Medical Device Clinical Evaluation and PMS
Embase Senior Product Manager: Dr. Ivan Krstic
About this talk
Information found in the biomedical literature is a significant source for every stage of the medical device life cycle, from concept and design through clinical trials to release and reimbursement, as well as post-market surveillance.
In June 2016, the updated Medical Device Clinical Evaluation Report (CER) guidelines came into effect (Revision 4 of MEDDEV 2.7/1), detailing where and how to search for literature and how to record the process of collecting, appraising and analyzing the items found.
In this session, Elsevier's senior product manager Dr. Ivan Krstic demonstrated how Embase is especially suited to help Medical Device manufacturers prepare CER, including:
- How to design effective literature searches for Clinical Evaluation reports using the PICO search form in Embase;
- How to build a more comprehensive search using Emtree terms and synonyms;
- How trade name and manufacturer name indexing supports analyses of devices already on the market;
- How to find mentions of adverse device reactions in the literature for effective post-market surveillance (PMS) reporting