3Aware
Shelly Gladish Simeone is currently the Senior Vice President of Legal and Chief Compliance Officer at 3Aware. Prior to this role, Shelly held similar positions at hc1. Shelly also served as a Director-at-Large at Business and Professional Exchange and has experience in contract negotiations and administration at Roche Diagnostics and Kaplan Compliance Solutions. With a background in leading compliance programs, negotiations, and overseeing legal processes, Shelly has demonstrated a strong track record of ensuring regulatory compliance and driving operational efficiencies.
3Aware
3Aware supports immediate access to real-world clinical data for medical device manufacturers in a self-administered platform. MedTech Clinical and Regulatory teams spend exorbitant time and money on the real-world data collection to support keeping devices on the market. With a host of patchwork solutions, there remains no solution to meet their clinical data needs reliably, quickly and affordably. The 3Aware solution provides immediate Access to real world data for device encounters, the ability to Analyze the data for inclusion/ exclusion for PMCF reporting and Alerts to safety and performance of devices. Our solution saves Medtech time and money spent on clinical data acquisition for the purpose of Post Market Surveillance.