Medical Device Overview and Its Application to Pharmaceutical Products

Seminar #14: Wednesday, May 17th, 13:00 – 17:00

Carey Smoak, DataCeutics, Inc.


The purpose of this seminar is to provide an overview of the process of getting medical devices approved / cleared, to give an overview of CDISC for medical devices and to give an overview of the overlap between medical devices and drug / biologic products. With regards to the latter, examples of combination products (device and drug / biologic products) will be illustrated. Moreover, seventeen out of twenty-four Therapeutic Area User Guides (TAUGs) use all seven of the medical device domains (SDTMIG-MD). Additionally, the Associated Persons Implementation Guide (SDTMIG-AP) includes examples of device data for non-subjects in a clinical trial. The intended audience is both people in the medical device industry and the pharmaceutical / biotech (drugs / biologics) industry. This workshop is not just for medical device professionals. Pharmaceutical professionals will benefit from this workshop as medical device data is being used in TAUGs, Associated Persons (SDTMIG-AP) and in combination drug-device products.