The 3Aware Platform
3Aware supports medical device manufacturer PMCF needs through:
sourcedfrom patient records.
summarizesafety and performance data to drive deeper insights in a collaborative system.
supplydata to drive real-time action.
In three simple steps, 3Aware
aiSurveillanceplatform equips MedTech manufacturers to access real-world data and independently analyze patients, encounters & devices for PMCF reporting, quickly and affordably. This enables manufacturers to feasibly fulfill FDA post-approval studies, as well as EU MDR regulatory requirements, equipping them for future regulatory development. We enable evidence, based on real-world clinical data to ensure devices go to and stay on the market.
Self-administer the post-market data lifecycle.
3Aware data is directly sourced from leading health systems within the United States that have linked medical device identification to unique patient encounters. Real-world data from 3Aware is patient level and device specific.
The 3Aware solution is a Software-as-a-Service application purpose-built for healthcare and the medical device industry by leading healthcare experts. The 3Aware solution is powered by and hosted on a HITRUST® 2-year (r2) certified platform, as the 3Aware solution is powered by the HITRUST certified hc1 Platform®. Additionally, the corporate headquarters in Indianapolis, IN, where the 3Aware services are performed, meet the HITRUST® Risk-based, 2-year (r2) certification criteria.
The (r2) validated assessment certification is a tailored, independent, third-party assessment for the highest level of assurance that an organization may earn from HITRUST.
Please visit the HITRUST (r2) Certification page for more information at https://www.hc1.com/platform/hitrust/