Global Medical Device Podcast Powered By Greenlight.guru

Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Adam Steadman, Chief Commercial Officer for SMART-TRIAL, about best practices⁠—not shortcuts⁠—to bridge the gap between medical devices and clinical data.SMART-TRIAL is an Electronic Data Capture (EDC) company that provides software as a service (SaaS). The EDC software generates, collects, and manages data used in clinical studies.Some of the highlights of this episode include:EDC is a newer concept or discipline for the medical device industry. Compared to the pharmaceutical space, automation from the clinical trial perspective has been a bit slower because of smaller sample sizes.Post-market surveillance activities are driven by EU MDR. In Europe, medical device companies are now being forced to prove to the world that their device continues to be effective against its peers and new pr